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Results You Can Expect

Specific examples of the results you'll receive when we're a part of your development team include:
  • Clear explanations of conformity assessment options of EU Medical Device Directive (MDD,  93/42/EEC), or EU In Vitro Diagnostic Device Directive (IVDD, 98/79/EC), tailored to your firm's size, maturity of quality system, and time to market requirements.
  • Suggested improvements to quality system procedures to reduce non-compliance issues during product design, production, and post-market, and in-line with FDA and EU Notified Body expectations.
  • Hazard identification and state-of-the-art, cost effective risk control (mitigation) strategies.
  • Design input to prevent and/or work-around product safety non-compliance issues in a cost effective and timely fashion
  • Clear explanations of design alternatives illustrated with insulation diagrams, including discussions of pros and cons of each alternative
  • Techniques to integrate non-medical equipment (e.g. IT, IEC 60950, machinery, IEC 60204; or lab, IEC 61010) into medical systems, saving money, and allowing state-of-the-art accessories to reach the patient
  • Practical ability to tag safety critical components and materials, and know minimum controls needed
  • Approval of in-house test facilities for supervised testing by third party certification bodies, such as UL, Intertek/ETL, CSA, VDE, TUV PS, TUV Rh, UL/Demko, Intertek/SEMKO, KEMA and many others to international test laboratory quality system requirements, ISO/IEC 17025.
  • Compliance with electrical medical device safety requirements of IEC 60601-1 (medical), or IEC 61010-1 (IVD), or IEC 14708 (implant), including any applicable collateral and/or particular parts. Providing assessment reports, if desired.
  • Compliance with software development and validation requirements of IEC 60601-1, clause 14, IEC 62304, IEC 80001, and FDA Guidance Docs. Providing assessment reports, if desired.
  • Liaison with all regulatory and safety organizations for approvals
  • Preparation of production safety testing procedures (i.e. leakage, dielectric, earthing), including sourcing of appropriate test equipment
  • Timely advise on effective dates for new standards, amendments, and guidance.  Gap analysis and impact reviews for new and existing designs to comply.
  • Practical application knowledge of electrical medical device safety requirements, IEC 60601, and electrical IVD devices, IEC 61010, series of standards through classroom training and hands-on laboratory testing focused on your products
  • Practical application knowledge of the regulatory risk management driven product development life cycle process that's encouraged by FDA, the EU MDD and EU IVD, and the international standards ISO 14971 and 13485, through classroom training.
Approvals  

 On-Time Production

 Reduction in Expenses