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IMed Consultancy releases guide to market entry for medical devices sector

IMed Consultancy, a rising regulatory and compliance consultancy provider, has launched a guide to market entry looking at the EU, the UK and the US.

The whitepaper, available at: https://imedconsultancy.com, looks at these three major markets for medical devices, highlighting some key considerations relating to entering each of these geographies, to help manufacturers make informed decisions.

In today's rapidly evolving landscape of healthcare and technology, navigating the realm of regulatory compliance for medical devices has become an increasingly complex endeavour. With advancements in medical technology, the development and deployment of innovative devices have brought forth immense opportunities for improving patient care and revolutionising the healthcare industry. At the same time, however, major markets such as Europe and the UK are experiencing unprecedented regulatory shake-ups in the form of the introduction of the new EU MDR and IVDR and the Future UK Regulatory System.

These regulations aim to safeguard patient safety, ensure device effectiveness, and maintain ethical standards throughout the product lifecycle, from design and manufacturing to post-market surveillance. However, achieving regulatory compliance in this intricate landscape is no simple task. It requires a deep understanding of the evolving regulatory landscape, meticulous planning, robust quality management systems, and effective risk assessment strategies.

“Manufacturers and stakeholders must navigate through a web of complex standards, guidelines, and country-specific regulations before they decide which markets will be the most profitable to enter and which ones they should tackle first, laying the groundworks for further expansion in the most time-efficient and cost-effective way possible. We felt the need to try and untangle some of this web for them, to ease their decision process and to hopefully shed some light on the different opportunities these areas have to offer.” comments Leeanne Baker, Managing Director and Quality & Regulatory Consultant.

 

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Upcoming Events

The Operating Theatres Show 2023

Kia Oval, London
28th September 2023

Diversity, inclusion and equality in surgery conference

RCS England Headquarters, London, WC2A 3PE
30th September 2023

UK Respiratory Infections Seminar

Mary Ward House, London
4th October 2023

Ecolab's Public Health & Sustainability Day

Old Trafford, Manchester United
10th October 2023

CSC Autumn Study Day 2023

LMI conference centre, Liverpool
16th October 2023

Prevent, Protect, Provide: Minimising infections for patients and the NHS

The Clermont Hotel, London, WC2N 5HX
30th October 2023

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

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