We enable market access for medical devices and IVDs

Successful and legal marketing of your medical devices and in vitro diagnostics may only be ensured if you as the manufacturer comply with the target market’s regulatory requirements. These requirements are diverse and complex. As a service provider, we cover the full range of regulatory topics to provide optimum support to you at any point in the product cycle – from developing a new medical device or IVD, maintaining existing medical devices/IVDs or entering new target markets, to optimizing your quality management processes.

Metecon is your strategic partner across the entire product lifecycle. We are all ears and use our brains to create individual solutions for the approval of your device.

Our services at a glance

Facing challenges with a smile

True, the requirements for you as a manufacturer are enormous: The EU agrees on a new medical device regulation (MDR) in nearly no time and leaves manufacturers with an interim period of no more than three years to lift all medical devices to MDR level. MEDDEV 2.7/1 revision 4 increases the planning pressure on manufacturers: The notified bodies call for updated clinical evaluation already. And the ideas for software as a medical device often seem to be well ahead of its documentation.

Knowing that there is a partner at your side with comprehensive know-how and many years of experience with the documentation and approval of medical devices and IVDs along with their verification and validation, there is no need to worry. We are committed consultants and service providers. Together we make your project a success.

We look forward to getting to know you!

News

Safety und Security für Medical Device Software
April 2019

Safety und Security für Medical Device Software

Kurz erklärt: Warum Hacks (noch) so leicht sind und wie Sie Ihre Sicherheitslücken schließen
KI in der Medizintechnik: Regulatorische Anforderungen
April 2019

KI in der Medizintechnik: Regulatorische Anforderungen

Fachvortrag von Thorsten Stumpf beim IVAM Unternehmensforum
Verbraucheranwendung oder Medizinprodukt?
March 2019

Verbraucheranwendung oder Medizinprodukt?

Impulsvortrag von Alexander Fink beim MedTechDialog im CUBEX41 in Mannheim