Über uns

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).

Current and past Projects in several international companies include

· 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,I am providing safe, simple and sustainable solutions tailored to your needs on site.

Impressum: http://www.quality-on-site.com/impressum.php