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Absent MRA, immanent MDR: Actions for Swiss medtech

Absent MRA, immanent MDR: Actions for Swiss medtech

by Jasminka Roth and Deepa Rajagopalan, 17 January 2020

The situation around the bilateral agreements and the MRA (Mutual Recognition Agreement) between the...

Regulatory strategies for the MDR

Regulatory strategies for the MDR

by Jasminka Roth and Henrietta Shirley, 15 October 2019

Following the intensive workshop (Tactical Session) we recently presented in Schaffhausen—and reported in the...

Accessing funding and reimbursement in medtech

Accessing funding and reimbursement in medtech

by Jasminka Roth, 8 October 2019

Funding and reimbursement systems pay for medical devices. However, accessing these systems effectively and...

Evaluating your clinical data under the MDR

Evaluating your clinical data under the MDR

by Jasminka Roth, 1 October 2019

The MDR has left many manufacturers wondering whether they have enough clinical data to...

MDR & IVDR Tactical Session: working with a Notified Body

MDR & IVDR Tactical Session: working with a Notified Body

by Jasminka Roth, 24 September 2019

For many medtech companies, particularly SMEs, finding and working with a Notified Body can...

Medtech’s role in patient safety

Medtech’s role in patient safety

by Henrietta Shirley, 17 September 2019

Patient safety is key to strengthening and improving our healthcare systems, and medtech has...

How does regulation affect innovation?

How does regulation affect innovation?

by Deepa Rajagopalan, 10 September 2019

The human mind is curious. It is our inquisitiveness that has led to some...

The Medtech Diary: Swiss Digital Day

The Medtech Diary: Swiss Digital Day

by Henrietta Shirley, 27 August 2019

Next week, 3 September 2019, will be Swiss Digital Day—a national event initiated by...

Futureproofing Swiss healthcare

Futureproofing Swiss healthcare

by Henrietta Shirley, 20 August 2019

Healthcare is basically a process industry. As any professional manager from such an industry...

Key research for medical device manufactures

Key research for medical device manufactures

by Jasminka Roth, 13 August 2019

How does regulation affect innovation? We are built to explore, to travel, to move...

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