ISO 14155 Update: Key risk management changes for medical device clinical investigations in 2019

Futuristic HexagonsThe third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year.

According to the International Organization for Standards (ISO), the updated edition will focus on a more stringent risk management approach across all stages of clinical investigations from pivotal to Post-Market Clinical Follow-up (PMCF). Continue reading

How a No-Deal Brexit Might Affect Medical Device Development: Legal Consequences and Risk Mitigation Strategies

How could a no-deal Brexit affect my medical device lifecycle?

Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is Image of Flag of Great Britain Overlapped with United Nations Flagpossible that there could be a “no-deal Brexit” scenario.

The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical devices as companies face harsh penalties for violating EU law if they don’t comply; yet they still need to meet business obligations to stakeholders, clients and patients. The political and legal situation is still evolving, and this uncertainty raises many questions for the device development pathway. Continue reading