Medical Device

Entrepreneurialism is in the blood of Israel’s medtech innovators, but in a changing medtech world, the local ecosystem must address funding gaps and manufacturing and infrastructure needs. So says Ruti Alon, experienced Israeli medtech leader, investor and co-chair of the Biomed Israel conference.

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Without change, the implementation of the MDR and IVDR could hit another wall.

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.

There is still no clarity on how life sciences will be treated in the final agreement.

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.