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GMP for Medical Devices

prefilled syringes

GMP for Medical Devices

If you need GMP compliance support for medical devices, call +49 69 7909 340.

Our specialists will be happy to support you.

 
Content

The increasing co-operation of medical device manufacturers with pharmaceutical companies makes it necessary to approximate quality management system according to EN ISO 13485 to GMP requirements.

Valicare`s long-standing experience within the medical device, biotechnology, and pharmaceutical industry allows us to detect and implement necessary extensions in the quality management systems of our customers. Our services are based on international laws and regulations such as EU GMP guideline, 21 CFR (FDA) with cGMP, FDA Guidance for Industry documents as well as GHTF, PIC/S, ICH Guidelines and GAMP 5.

Our specially designed concepts cover:

  • GMP Auditing & Consulting with GAP-/Target-Actual Analysis
  • GMP Upgrade
  • „In House“ GMP starter and expert trainings
  • Good documentation practice
  • Establishment of training courses

We offer you a comprehensive service in order to implement the mandatory quality standards in development, manufacturing, packaging, storage, and logistics of your medical devices, companion diagnostics, and combination products including advanced therapy medicinal products.