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Redefining distributors in a new light

Redefining distributors in a new light

by Deepa Rajagopalan, 2 April 2019

The EU Commission’s new Medical Device Regulation (MDR) significantly changes the importance of economic...

5 Steps to an MDR Audit

5 Steps to an MDR Audit

by Jasminka Roth, 26 March 2019

As you read this, Notified Bodies (NB) are scheduling their first MDR audits—so we’ve...

Yannik Messerli on the art of data

Yannik Messerli on the art of data

by Henrietta Shirley, 19 March 2019

Henrietta Shirley talks to data strategist and infographic designer Yannik Messerli about mastering his...

Create a great Quality Management System

Create a great Quality Management System

by Deepa Rajagopalan, 12 March 2019

Quality is not subjective but defined by that which brings it into being. Classically...

Tracking the UDI System

Tracking the UDI System

by Deepa Rajagopalan, 5 March 2019

The Unique Device Identification (UDI) system defines the provenance of a medical device and...

Process mapping the route to compliance

Process mapping the route to compliance

by Denis Vörös, 26 February 2019

The medical device industry is built on defined processes. These make sure that tasks...

Harnessing the power of market transparency

Harnessing the power of market transparency

by Jasminka Roth, 19 February 2019

New regulations and initiatives are being built in Europe to create a more transparent...

Begin your data collection for the Eudamed today

Begin your data collection for the Eudamed today

by Deepa Rajagopalan, 12 February 2019

The European Databank on Medical Devices (Eudamed) will go live from the 25 March...

Secure your business in Europe through MDR compliance

Secure your business in Europe through MDR compliance

by Deepa Rajagopalan, 5 February 2019

The clock is ticking, and time is running out to prepare your organisations’ Medical...

Improving for today and the future

Improving for today and the future

by Denis Vörös, 29 January 2019

As we create, we hone our skills. During this process we begin to identify...

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Recent Posts

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    Process Improvement – QMS+ course with activities for children.

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    Process Improvement – QMS+ course with activities for children.

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    Absent MRA, immanent MDR: Actions for Swiss medtech

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