Safety Consulting and Testing

Gain Approvals

Our services make it easier to get your medical device through the design and approval process.  We're experts in medical device safety.

design process
Let Us Participate in Your Design Process

By participating in your risk assessment and design review meetings we're striving to prevent non-compliance issues, and provide practical support to your staff.  Should problems occur, we can usually help you resolve.

Design controls must be in place so there's traceability between safety risk driven requirements and testing.  The design process might be a linear water-fall type design process; or more often an iterative, converging design process.  With modular software, modular hardware, and 3D printing and/or milling, rapid prototyping is possible.  There's no longer the same penalties with quick prototyping and learning from formative testing.  It's not uncommon to see requirements evolve and converge towards the final product.  Especially with start-up firms, but true with any business, metrics like scheduling, budget, and acceptable testing must stay on track to ensure later stage funding.  We relish participating in this dynamic environment with our mission being to see that your product comply with regulatory requirements.

oz of prevention
We Help You:

Analyze, Specify Requirements

  • Identify applicable regulatory requirements (e.g. FDA, EU MDD)
    • Assist with device classification
    • Assist with compliance strategy
  • Identify applicable international safety standards
    • Quality, ISO 13485, QSR 21 CFR 820
    • Risk, ISO 14971
    • Usability/Human factors, IEC 62366
    • Software, IEC 62304, IEC 60601, IEC 81001
    • Basic Safety (energy, material related hazards), and Essential Performance (clinical performance related hazards), IEC 60601
    • EM (electromagnetic) disturbances, safety emissions and immunity, IEC 60601-1-2
    • EMC  (EM compatibility) non-safety performance immunity guidance, IEC TR 60601-4-2
    • Any collateral standards (e.g. alarms, home care, etc), IEC 60601-1-xx
    • Any particular standards (e.g. HF surgical, endoscopic, X-ray, Light-Ion, etc), IEC 60601-2-xx, ISO 80601-2-xx
    • Safety critical component standards, (e.g. lithium batteries, IEC 62133; lasers, IEC 60825, 21 CFR 1040; incoherent light sources, IEC 60471; etc)
  • Identify applicable hazards, conduct risk analysis, risk evaluation
  • Specify acceptable risk controls consistent with international standards, and the generally acknowledged state of the art
  • Assist with appropriate application and interpretation of product safety and EMC standards
    • Medical Devices, IEC 60601, ISO 80601 
    • Active Implants, ISO 14708
    • IVD Devices, IEC 61010
  • Support design processes for:
    • Risk Management, ISO 14971
    • Software Development Life Cycle, for safety and cyber security, IEC 62304, IEC 81001
    • Usability/Human Factor Engineering, IEC 62366

Test

  • Formulate test plans (Verification & Validation, or Formative & Summative) to demonstrate effectiveness of risk controls, including those related to usability (human factors)
  • Assist manufacturer with testing, and/or select suitable contractors to conduct testing
  • Provide liaison services for outside contracted test laboratories

gain approvals
Evaluate 

  • Resolve any testing problems, including with any external test laboratories
  • Assemble and organize records for inclusion into regulatory filings (e.g. FDA, EU Notified Body, etc):
    • Safety test reports
    • EMC test reports
    • Applicable risk summary/assurance case reports
    • Applicable software records and reports
    • Applicable usability (human factor) records, and formative and summative reports
  • Gain regulatory approvals