Michael Schaefer Quality Management and Regulatory Affairs

As an expert for Quality Management and Regulatory Affairs for Medical Devices, I am offering consultancy services for a wide range of international regulatory requirements as written down in standards and regulations
(like ISO13485, ISO14971, 21CFR820, 93/42/EEC, new MDR). Current and past projects in several international companies include
– Process Validation IQ, OQ, PQ
– Notified Body Audit & FDA Inspection Readiness
– Interim Quality Management (MDD Class I-III)
– Design Control for drug device combination products
– Internal and Supplier Auditing
– Production Transfers, Process and Cleanroom Validations

Based on a long-year experience in both development and operations,
Working both onsite and remote, I am providing safe, simple and sustainable solutions tailored to your Needs.

Company’s Keywords:

medical devices, fda, iso 13485, mdd, mdr