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process improvement champion


Medical Devices

Complying with regulatory systems needed to market devices worldwide.

Ainslie’s experience as a participant in the medical device industry coupled with Alan Broadwin’s qualifications and track record of helping companies bring their products to market in this highly regulated field will enable you to understand how you can better meet customer and regulatory requirements.

Medical Devices

If you are in the process of implementing a mandated quality system or working to improve it, ask Alan Broadwin to help you:

  • Understand the importance of ISO 13485 in the United States, Canada and Europe.
  • Differentiate between ISO 13485 and ISO 9001
  • See how the elements of ISO 13485 are supported by guidance from ISO 14969
  • Understand the relationship between ISO 13485 and ISO 14971
  • Compare the requirements of ISO 13485, the FDA’s QSR, Canada’s CMDCAS, and Europe’s Medical Device Directives and Essential Requirements.

Selected Associated Standards

  • ISO 13485Medical Devices - Quality Management Systems –Requirements for Regulatory purposes
  • ISO 9000Quality management systems- Fundamentals and vocabulary
  • ISO 9001Quality management systems- Requirements
  • ISO 9004Quality management systems- Guidelines for performance improvements.
  • ISO 19011Guidelines for Auditing Quality and Environmental Management Systems
  • ANSI Z1.4Sampling Procedures and Tables for Inspection by Attributes
  • ISO 10012-1Calibration System Requirements
  • 21 CFR 820FDA Quality System Requirements
  • SOR/98-282Canadian Medical Device Regulations
  • 93/42/EECMedical Device Directives
  • ISO 14971Risk Management for Medical Devices

Give your company the edge.  Ask Alan Broadwin to help you navigate the latest revisions to the standards and requirements.  Contact quality management consultant Alan Broadwin at (914)948-1498, for expert business advice.