quality control for medical products

We are specialised in the analytical testing and quality control of borderline medical devices as well as medical devices with ancillary drug substances, where we can draw on our many years of experience.

For combinational medical products, all quality-information have to be prepared according to directive 2001/83/EC and the relevant quality guidelines. We offer you all required services for a consultation procedure according to MEDDEV- and MDD-guidelines and for Scientific Advice-meetings with the Notified Bodies and/or the responsible regulatory authorities.

We develop and validate analytical methods for identity testing, assay, purity testing, as well as dissolution testing of pharmaceutical drug substances in combination products according to national and international guidelines and standards. We conduct analytical testing for batch release and stability according to defined specifications within the context of quality control of borderline medical devices as well as medical devices with ancillary drug substances.

Contact:
Christiane Wiegand
, Head of Laboratory Services
Email: c.wiegand(at)hwi-group.de
Phone: +49 7272 7767-2521

Dr. Melanie Kerst, Managing Director
Email: m.kerst(at)hwi-group.de
Phone: +49 7272 7767-2510

Medizinprodukte klein
 

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