North American Medical Device Quality Control Recommendations: Part 2

Preventative Activities:

Preventative activities keep defects from occurring in the first place, rather than fixing them after they have occurred. These include:

• Best Practices for product design (i.e., apply the process, stay the course, stick to your guns):
  
  
  1. Clearly spell out the new product features and functions, and applicable certification/regulatory compliance standard stated in the device specification or Requirements document.
  2. Define the (geographical) markets, define regulatory standards the new product must comply with.
  3. Defined development project steps with clearly assigned responsibilities, due dates, milestones, notifications, and approvals.
  4. Include Partners (component manufacturers, distributors, certification labs) to validate the chitectural solution and verify components availability, component life cycle stage and the standards to design against.
  5. Apply sound engineering design principles.
  6. Regular design peer reviews: schematics, PCB layouts, BOMs, firmware, cloud/mobile device software code, Industrial Design, and Mechanical design to reduce the number of hardware related issues, firmware, and software bugs.
  7. Prototype often and repeatedly and test, test, test (i.e., verify) at every step of development.
  8. Regular communication between design and technical staff and client counterparts, to resolve discrepancies, uncertainties, and new requirements.
  9. Ensure that MD prototypes, pilot build products are evaluated by the end customer using stated end users as often as possible.
  10. Involve the ISO 17025:2016 accredited Certification Accredited Body (test lab) accredited to the specific ISO, IEC, ASTM, CSA and / or UL standards per the general and specific Medical Device standards early in the MD Design process. The applicable standards can be found on FDA consensus standard database, and the Health Canada recognized standards document.
  
  

Product Quality Verification Activities:
Quality verification activities are used to identify issues early in product development so they can be rectified before major problems occur at pilot build or product release stages. These steps help ensure that the product meets both technical specifications and real-world expectations:

• Testing:
  
  
  1. Hardware bring-up tests, and FW code integration verification testing to ensure HW and FW code compatibility.
  2. Mechanical fit and usability testing to estimate design reliability and ease of use by identified groups: a) First Responders, b) trained medical professionals (physicians, nursers, orderlies) and c) home end users/patients (child, young adult, mature adult, elderly).
  3. Environmental testing to estimate design reliability.
  
  
• Engineering change control:
  
  
  1. Any subsequent design changes related to the above activities should be clearly documented via controlled Engineering Change Notice (ECN) or Engineering Change Order (ECO) process approval workflow.
  
  
• Pre-Certification & pre-release safety/regulatory compliance testing:
  
  
  1. Proper pre-certification testing (e.g. EMC/EMI per specified regulations/standards) testing to find potential non-conformances before full certification efforts.
  2. Pre-final production release safety and/or regulatory compliance testing (i.e., EMC/EMI, RF Exposure/SAR Absorption, frequency allocation/stability, and spurious emissions) are legally required and should be performed by an ISO 17025:2016 accredited certification body (test lab) actively accredited to those regulations/standards.
  
  
• Instructions for use/user manual review:
  
  
  1. All product instruction/user manuals should be reviewed by trained staff for adherence to key product features, ease of use, readability, and listing of certification/regulatory compliance standards/regulation manual requirements.
  
  
• Verification with end users (home healthcare) or trained medical professionals (hospitals, clinics):
  
  
  1. Where feasible, conduct early-stage verification with end users, stakeholders, or focus groups. This may include hands-on testing, usability evaluations, or simulated use-case scenarios to gather feedback on product performance, feature completeness, and user experience.
  
  

Product Quality Validation Activities:
Verification asks whether the product meets its specified requirements. Validation goes one step further: does the product actually meet the needs of its intended users and intended use environment?

• Quality Assurance (QA) inspection and validation testing:
  
  
  1. Comprehensive reviews of mechanical design, hardware design, firmware embedded code and /or software application to rule out any non-compliances to stated electronic product critical requirements, including worst-case environment.
  2. QA findings and/or test case issues are clearly stated in a recognized Agile or JIRA type tracking software per-project for traceability.
  
  
• Validation of the manufacturing process with the manufacturing staff:
  
  
  1. Create work orders based on estimated volumes to validate that the received materials, specified machines, tools, accessories, inspection, regulatory compliance, functional testing (including test fixture and specific test software) and packaging activities can create the medical device correctly per end user needs efficiently, reliably, and consistently. Component failures/rejects, excessive lead times, poor assembly documentation, test failures can lead to medical device defects, requiring unexpected rework or re-design.
  
  
• Post-market surveillance & complaints of field performance data by end users/ operators or patients:
  
  
  1. Provide easy means to record (dedicated web site, user manual digital forms, etc.) and track posts and comments on the medical device usability, and unexplored field issues (e.g. Rare low-probability hazards, unexpected misuse, environmental challenges and cybersecurity threats/vulnerabilities). This feedback comes from trained professionals, operators in hospitals and clinics or from end user patients in home healthcare environment.
  
  

A successful medical device development process connects requirements, risk management, engineering, testing, manufacturing, regulatory compliance, and user feedback from the beginning of the development effort.

For companies developing electronic medical devices, this integrated approach can help reduce late-stage surprises, control development costs, improve reliability, and ultimately deliver safer and more effective products to the market.

That is where NeuronicWorks can help.

With experience spanning electronics design, embedded firmware and software, mechanical engineering, prototyping, verification and validation, regulatory compliance support, manufacturing, and production testing, NeuronicWorks can support medical device companies through multiple stages of the product lifecycle.

Whether the challenge is developing a new product, updating an existing platform, preparing for production, or improving a manufacturing and testing process, our multidisciplinary team can help bring engineering and manufacturing together earlier in the process.