Medical Devices Compliance

Your contact person: Martin Rümke

The Route to Compliance

Our experienced consultants support you in all aspects of cost-conscious implementation of regulatory requirements for medical technology, the qualification of employees, suppliers and subcontractors, and other issues of inspection-proof quality management. This enables you to ensure consistently high product quality throughout the entire supply chain. Our goal is not a single assignment, but rather a long-term business relationship.

Our Role in Your Company

Depending on the issue or task at hand, Chemgineering can play various roles in your company - what role would you like us to play?

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Quality Management

Our experience is your advantage. Quality management ensures the systematic fulfillment of statutory requirements. A manufacturer specifies how and with what resources he ensures compliance. The rule that what is not described and signed did not take place applies!

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Regulatory Affairs

Your guide through the legal jungle. What applies and what’s necessary? The legal requirements are diverse and complex; pursuing the wrong path or going in the wrong direction can wreak havoc with your medical device! Chemgineering as your guide and partner.

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Qualification & Validation

Your strategist for practical applications.  The relevant authorities believe that qualification and validation of your processes ensure the performance and safety of your medical devices! Chemgineering as your partner and strategist for mastering these challenges practically and sustainably over the long term.

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Chemgineering Business Design AG | Binningerstrasse 2 | 4142 Münchenstein | T +41 61 467 89 00 | F +41 61 467 89 01 | www.chemgineering.com | info@chemgineering.com