Medical  Device  &  QA  Consultancy

Medical Device Safety and Regulatory Affairs Consultancy

Summary of Services Offered

• Medical Device Directive strategies - All Classes of Device including Sterile.  Also Class I  "Self Certification Distance Strategy" - provision of a "Do It Yourself" manual, with full guidance.

• Post Sales Issues Vigilance, Adverse Incident Reporting, Post Market Feedback systems

• Design Control - Product Safety, New Product Development, Product Approvals

• Authorized Representative Services Two Levels of Service - "STANDARD" covering complete Regulatory requirements including all Post Sales Issues -  "PREMIUM" includes all "Standard" requirements plus   additionally a Tailor Made package to meet all your Pre Sales Requirements also.

• Own Brand (Private) Labelling Own Branding where you Label existing Products with your own Brand Name.

• Quality Management Systems Complete confidential support for any National, International or Gloabl QMS, including ISO 9001:2000, ISO 13485:2003, FDA 21 CFR 820 QSR,

• Medical Device & QA Consultancy's Full range of Services

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