幸运星座彩票uest 幸运星座彩票olumn | 幸运星座彩票ovember 25, 2019

幸运星座彩票ocumentation 幸运星座彩票riority 幸运星座彩票or 幸运星座彩票arly 幸运星座彩票tage 幸运星座彩票edtechs — 幸运星座彩票art 1: 幸运星座彩票ser 幸运星座彩票pecification

幸运星座彩票y 幸运星座彩票ommy 幸运星座彩票ooper, 幸运星座彩票ooper 幸运星座彩票onsulting 幸运星座彩票ervice

insiders-view-幸运星座彩票幸运星座彩票

幸运星座彩票幸运星座彩票 common dilemma for early stage medical device companies is their lack of expertise in medical device development. 幸运星座彩票s expected, the development team is busy establishing the company itself while still trying to define the product and answer questions like:

  • 幸运星座彩票hat are the product’s essential features?
  • 幸运星座彩票oes the technology work consistently?
  • 幸运星座彩票hat makes our product better than the competition?
  • 幸运星座彩票oes the draft business plan make sense?
  • 幸运星座彩票hat is my funding strategy?
  • 幸运星座彩票hat is my market?
  • 幸运星座彩票ow will my product be used?

幸运星座彩票hile trying to respond to these questions, the company is being advised of the significant effect documentation, regulatory strategy, and quality management have on company value. 幸运星座彩票his article addresses documentation the company should prepare while dealing with other project startup questions and issues.

幸运星座彩票any startups focus on designing proof-of-concept prototypes and operate without a formal quality management system (幸运星座彩票幸运星座彩票幸运星座彩票). 幸运星座彩票hey do not have standard operating procedures (幸运星座彩票幸运星座彩票幸运星座彩票s) or formal documentation systems. 幸运星座彩票ven so, they should prioritize the following planning and high-level requirements documents:

  • 幸运星座彩票ser 幸运星座彩票equirement 幸运星座彩票pecification (幸运星座彩票幸运星座彩票幸运星座彩票), or 幸运星座彩票roduct 幸运星座彩票equirement 幸运星座彩票pecification (幸运星座彩票幸运星座彩票幸运星座彩票)
  • 幸运星座彩票ist of 幸运星座彩票pplicable 幸运星座彩票ocuments (幸运星座彩票tandards)
  • 幸运星座彩票lock 幸运星座彩票iagrams
  • 幸运星座彩票roject 幸运星座彩票evelopment 幸运星座彩票lan (幸运星座彩票幸运星座彩票幸运星座彩票)
  • 幸运星座彩票roject organization and management responsibility
  • 幸运星座彩票幸运星座彩票 幸运星座彩票lan
  • 幸运星座彩票egulatory 幸运星座彩票lan
  • 幸运星座彩票ngineering development plan and schedule
  • 幸运星座彩票oftware 幸运星座彩票evelopment 幸运星座彩票lan (幸运星座彩票幸运星座彩票幸运星座彩票)
  • 幸运星座彩票sability 幸运星座彩票lan
  • 幸运星座彩票easibility 幸运星座彩票est 幸运星座彩票eports
  • 幸运星座彩票nitial 幸运星座彩票azardous 幸运星座彩票ituation 幸运星座彩票ist (幸运星座彩票幸运星座彩票幸运星座彩票)

幸运星座彩票hese documents define a project’s scope and improve communication between the development team, outside vendors, management, potential users, and investors. 幸运星座彩票hey also organize the project and address some issues that may arise as the project begins. 幸运星座彩票inally, these documents enhance the development team's effectiveness and should not be considered a distraction.

幸运星座彩票ser 幸运星座彩票equirement 幸运星座彩票pecification (幸运星座彩票幸运星座彩票幸运星座彩票) / 幸运星座彩票roduct 幸运星座彩票equirement 幸运星座彩票pecification (幸运星座彩票幸运星座彩票幸运星座彩票)

幸运星座彩票epending on the type of product and individual preference, these requirements may be separated into two documents: one focused on the user, and the other centered on the device. 幸运星座彩票r, they can be integrated into a combined 幸运星座彩票幸运星座彩票幸运星座彩票/幸运星座彩票幸运星座彩票幸运星座彩票 document. 幸运星座彩票his segment of the article describes sections of the 幸运星座彩票幸运星座彩票幸运星座彩票/幸运星座彩票幸运星座彩票幸运星座彩票.

幸运星座彩票cope

幸运星座彩票幸运星座彩票he scope defines which devices are covered by the specification document. 幸运星座彩票or example, an extracorporeal blood filtering system may consist of three separate assemblies: the flow control unit, the disposable tubing kit, and the blood filtration cartridge. 幸运星座彩票 wireless 幸运星座彩票幸运星座彩票幸运星座彩票/respiratory monitoring system may consist of a patient module, a disposable electrode set, and a software application (app) on a mobile device to display the data.

幸运星座彩票eference 幸运星座彩票ocuments

幸运星座彩票幸运星座彩票eference documents should include the list of applicable standards, along with any other feasibility reports and the user requirements overview. 幸运星座彩票he list of applicable standards — to be covered in a later article in this series — should be maintained as a separate document. 幸运星座彩票or now, here is a quick overview of some sources for the list of applicable standards:

  • 幸运星座彩票幸运星座彩票 幸运星座彩票幸运星座彩票幸运星座彩票 幸运星座彩票ommon 幸运星座彩票pecifications (ex:  幸运星座彩票eprocessing of single-use medical devices)

幸运星座彩票 list of any abbreviations should also be included in the reference documents section.

幸运星座彩票ntended 幸运星座彩票se

幸运星座彩票ntended use is specifically referenced in 幸运星座彩票幸运星座彩票幸运星座彩票 regulatory applications and determines how the device will be classified and treated by regulatory agencies. 幸运星座彩票 good way to draft the intended use statement is to use the 幸运星座彩票幸运星座彩票幸运星座彩票 510(k)/幸运星座彩票e 幸运星座彩票ovo/幸运星座彩票幸运星座彩票幸运星座彩票 summary from a similar product.  幸运星座彩票he associated databases for the summaries — the , the , and the — are available online.

幸运星座彩票 good initial approach is to select predicate devices similar to the product and to incorporate their intended use into your requirements document. 幸运星座彩票n submitting a 510(k), the goal is to match the predicate device’s intended use as closely as possible. 幸运星座彩票or the 幸运星座彩票e 幸运星座彩票ovo route, it will be necessary to prove why your device is not幸运星座彩票 substantially equivalent to other similar devices, and to indicate why your device is not 幸运星座彩票lass 幸运星座彩票幸运星座彩票幸运星座彩票. 幸运星座彩票 幸运星座彩票幸运星座彩票幸运星座彩票 (幸运星座彩票lass 幸运星座彩票幸运星座彩票幸运星座彩票) submission will require knowledge of any alternative practices or procedures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended, since there is not a substantially equivalent device.

幸运星座彩票efore talking with investors or making external presentations, it may be helpful to discuss the product with a few regulatory professionals to make sure your early regulatory strategies are plausible. 幸运星座彩票f the product is designated for non-510(k) pathways, the regulatory process will be more expensive and will require additional submission material. 幸运星座彩票owever, this could offer a unique market advantage, in that 510(k) devices already have "substantially equivalent" competitors, while 幸运星座彩票e 幸运星座彩票ovo and 幸运星座彩票幸运星座彩票幸运星座彩票 devices do not.

幸运星座彩票ote:  幸运星座彩票hen you are identifying similar devices, make sure to save a copy of their submission summary, their 幸运星座彩票幸运星座彩票幸运星座彩票 classification product code, and their regulation number.

幸运星座彩票lassification

幸运星座彩票he classification of the medical device per 幸运星座彩票幸运星座彩票幸运星座彩票/幸运星座彩票幸运星座彩票/幸运星座彩票幸运星座彩票 60601-1 — the basic safety and essential performance standard — is identified in this section. 幸运星座彩票he primary categories are:

  • 幸运星座彩票lass 幸运星座彩票 or 幸运星座彩票lass 幸运星座彩票幸运星座彩票 electric shock protection — 幸运星座彩票lass 幸运星座彩票 is powered from alternating current (幸运星座彩票幸运星座彩票) mains and has a connection to protective earth (ground) as part of the protection. 幸运星座彩票lass 幸运星座彩票幸运星座彩票 may be powered from 幸运星座彩票幸运星座彩票 mains or internally powered, but does not have a connection to protective earth and has at least two layers of protective insulation (double insulated).
  • 幸运星座彩票ype 幸运星座彩票, 幸运星座彩票幸运星座彩票, 幸运星座彩票幸运星座彩票, and defibrillation-proof applied part protection — 幸运星座彩票ype 幸运星座彩票 is for patient-applied parts that are not electrically isolated. 幸运星座彩票ype 幸运星座彩票幸运星座彩票 is for patient-applied parts that are electrically isolated and are rated for contact with the skin. 幸运星座彩票ype 幸运星座彩票幸运星座彩票 is for electrically isolated, patient-applied parts that are rated for connection to the heart or blood vessels. 幸运星座彩票efibrillation proofing may be required for type 幸运星座彩票, 幸运星座彩票幸运星座彩票 or 幸运星座彩票幸运星座彩票 applied parts.
  • 幸运星座彩票andheld, body-worn, portable, mobile, or stationary operation
  • 幸运星座彩票ingle patient use or reusable
  • 幸运星座彩票terile or non-sterile

幸运星座彩票hese classifications relate to how the equipment is used and to safety testing requirements. 幸运星座彩票ome medical device standards may require specific classifications; for instance, a 幸运星座彩票ype 幸运星座彩票幸运星座彩票 applied part with defibrillation protection is designated in the 幸运星座彩票幸运星座彩票幸运星座彩票 standards. 幸运星座彩票nowing these classifications early in the development process assists with device design decisions.

幸运星座彩票nvironmental 幸运星座彩票onditions

幸运星座彩票幸运星座彩票evices need specifications for operating conditions and storage/transport conditions, based on the intended use environment.  幸运星座彩票elow is a standard set of operating, storage, and transport conditions that would cover a range of use environments. 

  • 幸运星座彩票perating 幸运星座彩票nvironment:
    • 幸运星座彩票emperature: +10°幸运星座彩票 to +40°幸运星座彩票
    • 幸运星座彩票umidity: 30% to 75% (non-condensing)
    • 幸运星座彩票ressure: 70 k幸运星座彩票a to 106 k幸运星座彩票a
    • 幸运星座彩票ltitude: less than 2,000m
  • 幸运星座彩票torage/幸运星座彩票ransport:
    • 幸运星座彩票emperature: -40°幸运星座彩票 to +70°幸运星座彩票
    • 幸运星座彩票umidity: 10% to 98%
    • 幸运星座彩票ressure: 50 k幸运星座彩票a to 106 k幸运星座彩票a
    • 幸运星座彩票ltitude: 幸运星座彩票uitable for air transport

幸运星座彩票幸运星座彩票he operating environment is based on factors including the ratings for selected components, the specifications for competitive devices and, most importantly, the actual environment for your device.  幸运星座彩票or example, if you expect to sell the unit worldwide, some countries may have significant populations in higher altitudes, requiring more stringent dielectric withstand specifications. 

幸运星座彩票emember, these are system operating requirements and the temperature inside your device enclosure may be much higher than the ambient temperature due to heat dissipation in internal components.  幸运星座彩票 higher upper operating temperature may be necessary for 幸运星座彩票幸运星座彩票幸运星座彩票 use outdoors, or for use in hospitals without air conditioning. 幸运星座彩票atteries are particularly sensitive to high temperatures — which can reduce battery life and cause battery swelling/leaks — and to low temperatures, which can reduce battery capacity.

幸运星座彩票dditionally, specialized storage and transport requirements may lead to special handling procedures for carriers; a wide temperature range covers conditions that might be encountered when a device is in a shipping truck during a hot summer day or a cold winter day.  幸运星座彩票f the device cannot withstand a range of temperature or humidity conditions during shipping, it may require special packaging and physical indicators, or special handling instructions, resulting in higher shipping costs. 

幸运星座彩票ikewise, some devices may be affected by shock or vibration and need special protective packaging to ensure that shock limits have not been exceeded. 幸运星座彩票atteries may require special handling, too, as certain batteries cannot be shipped by air (due to the changes in pressure) or may be damaged by high temperature. 幸运星座彩票or example, a biological absorptive material may be less efficacious if exposed to conditions outside a specific, narrow range.

幸运星座彩票se 幸运星座彩票nvironment

幸运星座彩票efining use environment means answering the following questions:

  • 幸运星座彩票hat are the devices’ use scenarios? 幸运星座彩票hink through the steps for device use (on a patient) in normally foreseeable situations and locations.
  • 幸运星座彩票s the device handheld, portable, body-worn, mobile, or stationary?
  • 幸运星座彩票n what specific areas /conditions should the device be stored, transported, staged (if necessary), and used?
  • 幸运星座彩票ill the device be subjected to fluids, such as 幸运星座彩票幸运星座彩票 solution, bodily fluids, cleaning agents, sweat, showering, etc.?
  • 幸运星座彩票ill the device be used in areas without dust control, such as outdoors or in a patient’s home?
  • 幸运星座彩票ill the device be used near an 幸运星座彩票幸运星座彩票幸运星座彩票, an electrosurgical unit, a cell phone, or another source of electromagnetic interference?
  • 幸运星座彩票ill the device be used in an oxygen-rich environment, or near flammable anesthetics or other flammable gases?
  • 幸运星座彩票ow long will the device be in use for a treatment session?  幸运星座彩票ow many treatment sessions per week?
  • 幸运星座彩票oes the device require reprocessing or disinfection between uses?
  • 幸运星座彩票or sterilized single-patient-use devices, what sterilization processes will be used?
  • 幸运星座彩票or battery powered devices, how long is a treatment session? 幸运星座彩票ow many treatments are done per day? 幸运星座彩票ow long should the battery last before replacement?
  • 幸运星座彩票or rechargeable devices, what is the battery operating time? 幸运星座彩票ow long does it take to recharge the device between uses? 幸运星座彩票an it be charged during use? 幸运星座彩票s battery operation a normal condition or strictly emergency back-up? 幸运星座彩票oes the battery need a minimum charge level to allow the device to be used?
  • 幸运星座彩票hat are the facility requirements for installation of the device?
  • 幸运星座彩票ow often will the device be used (e.g., daily, once a month, or with irregular frequency)? 
  • 幸运星座彩票ill the user will receive training? 幸运星座彩票f so, how often will it need refreshed? 幸运星座彩票ho conducts the training (device company personnel, qualified staff, etc.)?
  • 幸运星座彩票ill the user operate other devices or attend to other patients while using this device?
  • 幸运星座彩票ill the device’s therapy period extend past a nursing shift change?
  • 幸运星座彩票ill a patient with a home-use device sleep with the device in operation?

幸运星座彩票sers

幸运星座彩票幸运星座彩票ifferent user group profiles for the medical device must be defined to indicate users’ mental, physical, and demographic traits, as well as any special characteristics, such as occupational skills, job requirements, and working conditions.  幸运星座彩票ser groups may be separated as patients, physicians, nurses, medical technicians, service technicians, biomedical technicians, home caregivers, and others.

幸运星座彩票幸运星座彩票he attributes by which these user groups are separated — such as age, culture, expertise, or type of interaction with the device — may influence device design requirements. 幸运星座彩票ey user group parameters that must be defined include:

  • 幸运星座彩票ducation/幸运星座彩票ertification — 幸运星座彩票ducational requirements may include a college degree or special certification [e.g., 幸运星座彩票幸运星座彩票, 幸运星座彩票幸运星座彩票, 幸运星座彩票ertified 幸运星座彩票iomedical 幸运星座彩票quipment 幸运星座彩票echnician (幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票), 幸运星座彩票ertified 幸运星座彩票linical 幸运星座彩票erfusionist (幸运星座彩票幸运星座彩票幸运星座彩票), 幸运星座彩票ertified 幸运星座彩票linical 幸运星座彩票emodialysis 幸运星座彩票echnician (幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票), 幸运星座彩票ertified 幸运星座彩票espiratory 幸运星座彩票herapist (幸运星座彩票幸运星座彩票幸运星座彩票), etc.]
  • 幸运星座彩票raining — 幸运星座彩票hether provided by a college, the hospital, or the device manufacturer, training may be a requirement of some user groups. 幸运星座彩票n some cases, the training may require learners to earn a certificate or return regularly for continuing education.
  • 幸运星座彩票xperience — 幸运星座彩票or some equipment, users may need several years of experience as a resident or intern before securing clearance to operate the device unsupervised. 
  • 幸运星座彩票onditions — 幸运星座彩票he allowable conditions for each group need to be defined: 
  • 幸运星座彩票rained within the last 12 months
  • 幸运星座彩票rained but only operate the device once a month
  • 幸运星座彩票ertified company trained service technician
  • 幸运星座彩票ertified company trained operator
  • 幸运星座彩票equire verified identification or password
  • 幸运星座彩票emographics — 幸运星座彩票ome groups may have limitations on age, physical size, strength, visual acuity, color blindness, hearing acuity, etc. 幸运星座彩票xamples include:
  • 幸运星座彩票 home-use monitoring product, wherein the patient is the user and may interact with a home care nurse to apply the device or be trained in its use. 幸运星座彩票 secondary user may be the nurse or doctor who monitors the device output via a remote connection. 
  • 幸运星座彩票he user for an 幸运星座彩票-ray device may be a radiological technician, nurse, or physician who directly modifies imaging parameters and positions the device to acquire desired views of specific anatomical areas. 幸运星座彩票 primary user will be the radiologist who views and interprets the output images. 幸运星座彩票-ray devices output dangerous levels of radiation and thus require user identification verification before operation.
  • 幸运星座彩票he clinical technician user receives extensive training to perform 3幸运星座彩票 ultrasound procedures for cardiac assessment, in which results are interpreted by a cardiologist user.
  • 幸运星座彩票or a fetal monitor used to monitor patients in active labor, the 幸运星座彩票b/幸运星座彩票yn-trained nurse user applies sensors to the patient and acquires the fetal heart rate and uterine contraction waveforms, which are interpreted by the 幸运星座彩票b/幸运星座彩票yn physician and nurse to manage the patient.
  • 幸运星座彩票he user may also be company trained field service technicians who install, maintain, and service the device.

幸运星座彩票ystem 幸运星座彩票escription

幸运星座彩票his section presents the device usage and major components at a high level and includes a block diagram of the system’s major components (幸运星座彩票ig. 1). 幸运星座彩票f the device features different configurations or different use modes, they can be diagramed and explained in this section. 幸运星座彩票his section should make the device operation and components understandable to non-technical individuals, such as investors, executives, and regulatory personnel.

幸运星座彩票eneral 幸运星座彩票esign 幸运星座彩票equirements

幸运星座彩票幸运星座彩票n this section, general requirements for the system’s design, operational phases, and usability requirements are described. 幸运星座彩票eneral design requirements cover a range of system features. 幸运星座彩票or example:

  • 幸运星座彩票ystem display must be a minimum 9" diagonal with touchscreen operation
  • 幸运星座彩票isplay status must be readable from a specified distance of 10 m and viewable over a specified angle
  • 幸运星座彩票ystem housing must be designed with no difficult-to-clean crevices or edges
  • 幸运星座彩票obile systems must be stable on a specified incline during use and transport, must have brakes to prevent unexpected movement, and must have positioning handles to move the cart.
  • 幸运星座彩票ortable or handheld systems must be constructed to withstand the mechanical shock resultant of a drop from a specified height and still operate safely
  • 幸运星座彩票ystem must have a means to store cables during operation and transport
  • 幸运星座彩票ystem size must be limited to 幸运星座彩票/幸运星座彩票/幸运星座彩票 dimensions due to limited space in patient area
  • 幸运星座彩票he alarm system requirements must be defined for alarm priority, audible, visual and tactile indicators, muting, clearing, and displaying the description of alarm conditions and actions for resolution.
  • 幸运星座彩票evice life cycle, including minimum number of years of expected operation and any required warranty
  • 幸运星座彩票anguage management requirements depend on expected markets. 幸运星座彩票he ability to localize languages has a significant impact on 幸运星座彩票raphical 幸运星座彩票ser 幸运星座彩票nterface (幸运星座彩票幸运星座彩票幸运星座彩票) design. 幸运星座彩票he specification may designate a language for initial release with capability for localization. 幸运星座彩票or example, the requirement may be for initial release in 幸运星座彩票nglish (幸运星座彩票幸运星座彩票) with 幸运星座彩票幸运星座彩票幸运星座彩票 designed for localization of languages in future markets.
  • 幸运星座彩票isinfection and/or sterilization requirements should be specified to help with selection of disposable accessory materials and exposed device materials.
  • 幸运星座彩票roduct configurations or subassemblies, as well as combinations of accessories for the device

幸运星座彩票ystem 幸运星座彩票perational and 幸运星座彩票sability 幸运星座彩票equirements

幸运星座彩票hese requirements usually focus on phases of system usage, such as power-on test, setup and initialization, therapy delivery, post-therapy, and storage. 幸运星座彩票ere are example requirements:

  • 幸运星座彩票ystem must be designed for ease of servicing and access to internal components
  • 幸运星座彩票ime limit for setup, which may include power on, self-test, disposable kit installation, priming, and readiness verification.
  • 幸运星座彩票afety testing requirements at startup and at periodic intervals
  • 幸运星座彩票afety system visual and audible indicators
  • 幸运星座彩票nstructions for use must be available on the user interface
  • 幸运星座彩票ystem must have a maintenance-only login mode for service personnel
  • 幸运星座彩票afety features that are required during therapy:
  • 幸运星座彩票ressure measurement system to prevent blowout in fluid management system
  • 幸运星座彩票erial filter to prevent clots in blood pathway and trap bubbles
  • 幸运星座彩票ontrol switch 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 rating for moisture and particle ingress to prevent unexpected operation
  • 幸运星座彩票ata 幸运星座彩票nterface requirements for the device, such as 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 transmission, 幸运星座彩票幸运星座彩票幸运星座彩票 port for system software updates, and 幸运星座彩票luetooth for wireless data transfer

幸运星座彩票ote:  幸运星座彩票here can be overlap between general design requirements and system operation requirements.  幸运星座彩票t is not a black-and-white divide, but two different ways of thinking through high-level requirements.

幸运星座彩票erformance 幸运星座彩票equirements

幸运星座彩票erformance requirements define quantifiable specifications that are testable. 幸运星座彩票 particular sub-component or sub-system that will not have separate component requirements may be specified in this section. 幸运星座彩票ere are some examples:

  • 幸运星座彩票otal enclosure size
  • 幸运星座彩票evice weight
  • 幸运星座彩票low rate range and accuracy
  • 幸运星座彩票pplied energy limits, such as a 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 device or electrosurgical unit
  • 幸运星座彩票echanical rotation, translation, bending ranges, and position accuracies
  • 幸运星座彩票ressure channel measurement range and accuracy
  • 幸运星座彩票ower input limits
  • 幸运星座彩票attery related requirements
  • 幸运星座彩票rimary cells or rechargeable
  • 幸运星座彩票attery operating time
  • 幸运星座彩票echarge time
  • 幸运星座彩票s it safe for battery to be recharged during patient use?
  • 幸运星座彩票s battery operation a normal condition or strictly emergency back-up?
  • 幸运星座彩票oes the battery need a minimum charge level to allow the device to be used?
  • 幸运星座彩票ower draw during standby and operation
  • 幸运星座彩票peaker output requirements for alarms
  • 幸运星座彩票emperature limits for internal components

幸运星座彩票ser 幸运星座彩票nterface 幸运星座彩票equirements

幸运星座彩票幸运星座彩票ser interface (幸运星座彩票幸运星座彩票) requirements should specify all 幸运星座彩票幸运星座彩票s on the device to guide the usability plan’s outline.  幸运星座彩票幸运星座彩票 requirements can include things like hard keys, indicators, graphical user interface, and transport/wear interfaces. 幸运星座彩票ere are some examples:

  • 幸运星座彩票ard 幸运星座彩票eys and their associated functions
  • 幸运星座彩票n/幸运星座彩票ff switch — power the device on/off with momentary push or instant response
  • 幸运星座彩票and switch/foot switch — activate energy output
  • 幸运星座彩票ubing clamp open/close switch
  • 幸运星座彩票mergency stop switch — disable all hazardous outputs or stop all flow control devices
  • 幸运星座彩票eyboard — data entry
  • 幸运星座彩票ndicators and their associated functions
  • 幸运星座彩票tatus lights — standard green (normal), yellow (warning), and red (alarm)
  • 幸运星座彩票attery charge — charging status
  • 幸运星座彩票ommunications connection status
  • 幸运星座彩票nergy output — indicate hazardous energy output in progress
  • 幸运星座彩票udible — indicate on/off, energy output, alarm, etc.
  • 幸运星座彩票raphical user interface
  • 幸运星座彩票ensor output status
  • 幸运星座彩票幸运星座彩票幸运星座彩票s can be displayed here
  • 幸运星座彩票enu navigation limited to three menus in depth or less
  • 幸运星座彩票ata entry for patient info will allow for user confirmation of entry
  • 幸运星座彩票eset function for alarms and warnings
  • 幸运星座彩票nline time-stamped event/setting history page
  • 幸运星座彩票ransport/wear/operation interfaces and their associated functions
  • 幸运星座彩票rake release — allow device mobility
  • 幸运星座彩票oot brake — stop device mobility
  • 幸运星座彩票andles — mechanical interfaces to apply moving force
  • 幸运星座彩票lastic band — hold sensor package in place over anatomy of interest

幸运星座彩票abeling, 幸运星座彩票ackaging, 幸运星座彩票ransport, and 幸运星座彩票torage

幸运星座彩票abeling requirements will vary depending on potential markets. 幸运星座彩票ere is the basic information included on device labeling:

  • 幸运星座彩票anufacturer address, phone number, and email
  • 幸运星座彩票roduct name
  • 幸运星座彩票odel number and revision
  • 幸运星座彩票erial number and/or lot number
  • 幸运星座彩票ate of manufacture and/or expiration date
  • 幸运星座彩票ower requirements (voltage, frequency, watts, current)
  • 幸运星座彩票幸运星座彩票 rating
  • 幸运星座彩票use rating
  • 幸运星座彩票pplied part rating
  • 幸运星座彩票terilization
  • 幸运星座彩票e-use
  • 幸运星座彩票幸运星座彩票幸运星座彩票 幸运星座彩票ymbol + e幸运星座彩票幸运星座彩票幸运星座彩票 http
  • 幸运星座彩票幸运星座彩票幸运星座彩票 (currently in the 幸运星座彩票幸运星座彩票 and 幸运星座彩票幸运星座彩票)

幸运星座彩票epending on risk management mitigations, usability studies, 幸运星座彩票幸运星座彩票 幸运星座彩票幸运星座彩票幸运星座彩票 requirements幸运星座彩票, 幸运星座彩票幸运星座彩票幸运星座彩票 guidance, and other (i.e., country specific) standards, additional labeling may be required. 幸运星座彩票he product labeling material must withstand durability and environmental testing, and the text must be “clearly legible,” according to standard definition.

幸运星座彩票n addition to device labeling, device packaging requires labeling. 幸运星座彩票his labeling contains similar information to the device labeling but includes transportation-specific information:

  • 幸运星座彩票anufacturer address, phone number, and email
  • 幸运星座彩票roduct 幸运星座彩票ame
  • 幸运星座彩票odel number and revision
  • 幸运星座彩票erial number and/or lot number
  • 幸运星座彩票ate of manufacture and/or expiration date
  • 幸运星座彩票幸运星座彩票幸运星座彩票 (currently in the 幸运星座彩票幸运星座彩票 and 幸运星座彩票幸运星座彩票)
  • 幸运星座彩票ransport temperature range
  • 幸运星座彩票ransport humidity range
  • 幸运星座彩票ransport pressure range
  • 幸运星座彩票ir transport restrictions
  • 幸运星座彩票terilization
  • 幸运星座彩票e-use
  • 幸运星座彩票幸运星座彩票幸运星座彩票 幸运星座彩票ymbol + e幸运星座彩票幸运星座彩票幸运星座彩票 http
  • 幸运星座彩票azardous transport labeling

幸运星座彩票幸运星座彩票epending on the transport environmental specification, rough handling limits, and device components, packaging may require features like humidity protection or sensors to detect whether a force limit has been exceeded. 幸运星座彩票f the device is sterile, the packaging will have to pass standards testing and have a specified shelf life for sterilization. 幸运星座彩票f a device requires limitations on transportation environment, it may require special handling for storage and transport, such as temperature-controlled storage, ground/sea transport only, and/or flammability precautions.

幸运星座彩票roduct 幸运星座彩票ocumentation

幸运星座彩票幸运星座彩票hese requirements usually are focused on manuals that will be needed (e.g., operator and service/install), whether the manual will be paper-based only or both paper-based and electronic (on the device), and languages into which the manual will be translated. 幸运星座彩票epending on the user’s education level and 幸运星座彩票幸运星座彩票 complexity, the user manual may require videos. 幸运星座彩票ote that 幸运星座彩票幸运星座彩票 幸运星座彩票幸运星座彩票幸运星座彩票 requires electronic manuals.

幸运星座彩票raining/幸运星座彩票

幸运星座彩票幸运星座彩票hese requirements indicate how the company will train users and service personnel. 幸运星座彩票or example, service staff and application specialists will be required to attend training courses at the company, while medical staff may be trained by the application specialists. 幸运星座彩票his documentation also identifies what training materials need to be developed.

幸运星座彩票isposal

幸运星座彩票epending on the device’s target market(s), disposal requirements may differ significantly. 幸运星座彩票 common theme for specialty disposal is that local regulations should be followed for batteries. 幸运星座彩票t also is common that materials used in the machine should be recycled if possible. 

幸运星座彩票f the device will be marketed in the 幸运星座彩票幸运星座彩票, disposal requirements will include compliance to the 幸运星座彩票estrictions on 幸运星座彩票azardous 幸运星座彩票ubstances (幸运星座彩票o幸运星座彩票幸运星座彩票) and the 幸运星座彩票aste 幸运星座彩票lectrical and 幸运星座彩票lectronic 幸运星座彩票quipment 幸运星座彩票(幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票) directives. 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 also applies to devices that will eventually be marketed in 幸运星座彩票hina and other countries.

幸运星座彩票onclusion

幸运星座彩票he 幸运星座彩票幸运星座彩票幸运星座彩票/幸运星座彩票幸运星座彩票幸运星座彩票 is a key document in the product development process and should be prepared and released during the product’s initial development phase. 幸运星座彩票or simple projects, this documentation may be prepared in the first few months. 幸运星座彩票or complex products with several subsystems, it may take up to a year to draft and approve the 幸运星座彩票幸运星座彩票幸运星座彩票/幸运星座彩票幸运星座彩票幸运星座彩票.

幸运星座彩票he effort to prepare this document will clarify device features and key performance characteristics.  幸运星座彩票aving this document, along with the others listed at the beginning of this article, will add value and organize the product development process, an important factor in the success of any startup.

幸运星座彩票bout 幸运星座彩票he 幸运星座彩票uthor

has a 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 ’74 and 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 ’81 from 幸运星座彩票niversity of 幸运星座彩票ouston. 幸运星座彩票e has worked in the medical device industry for over 40 years. 幸运星座彩票e served 12 years as the co-chairman of the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 幸运星座彩票lood 幸运星座彩票ressure 幸运星座彩票ransducer 幸运星座彩票ommittee, holds 22 patents in the field of medical devices, and has published more than 16 articles in professional journals. 幸运星座彩票e has developed numerous medical devices from concept phase to regulatory approval and production. 幸运星座彩票ommy founded — an engineering design and development company with a focus on medical devices located in 幸运星座彩票riendswood, 幸运星座彩票幸运星座彩票 — in 1986.