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Committed to saving lives: IMed Consultancy and LifeVac Europe –

LifeVac Europe Limited, a family-operated business, is committed to saving lives by providing a non-invasive airway clearance device when standard choking protocols fail. The LifeVac device was invented by a close family friend Arthur Lih, after witnessing parents in hospital devastated due to losing their child who choked on a common grape. Since then, LifeVac has saved countless lives in various countries, including the USA, UK, Greece, and Canada. The device is FDA, MHRA, HPFB, MOH, AMAR, IMA, SAHPRA, TGA regulated and CE marked, making it a globally recognized life-saving tool. LifeVac Europe is also ISO 13485 accredited, ensuring that it meets stringent regulatory and quality management standards for medical devices.

Matthew Burton, IMed Consultancy’s Strategic Development Director, has been an essential partner to LifeVac Europe since day one. Matt and IMed have provided comprehensive regulatory support, to ensure continued compliance with the UK Sovereign Regulator, MHRA. IMed’s deep understanding of the regulatory landscape has enabled LifeVac to focus on its core mission—saving lives—while leaving the complexities of regulatory compliance to a trusted expert.

In recent years, IMed has assisted LifeVac Europe in several areas, from delivering essential regulatory training, to audits and clinical evaluations plans and reports, Post Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF).

In 2017, the MHRA imposed a temporary restriction on LifeVac, limiting its sales to the care sector, which required LifeVac Europe to meet stringent regulatory demands and reporting requirements for an innovative device intended for an unmet medical need. During this period, Matthew Burton worked tirelessly to help LifeVac Europe meet rigorous regulatory demands, including the preparation of detailed Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) reports on a quarterly basis until significant sufficient data was generated to allow the restrictions to be lifted in June 2023. After this point the device could now be used as intended.

Like many medical devices, LifeVac also faced challenges with customs and interpretation of rules under the new EU MDR when exporting in Italy and Spain. In these occasions, IMed stepped in as UK PRRC to resolve these issues, ensuring that LifeVac products could be distributed seamlessly in these regions.

“IMed has been with us since day one, providing not just regulatory expertise but also a human touch,” says Daniel Boland, QA/RA Manager at LifeVac Europe. “During times of critical need, IMed’s reliable, professional and knowledgeable approach has proved invaluable in supporting our mission.”

Matthew Burton, Strategic Development Director at IMed Consultancy, comments “Our relationship with LifeVac Europe is not only professional, but personal. It’s incredibly rewarding to see their life-saving technology continue to make a global impact. We are proud to be a part of their journey.”

IMed’s consistent support and regulatory expertise have enabled LifeVac Europe to maintain compliance across multiple jurisdictions, ensuring that the company can focus on what it does best—saving lives.