Supporting your introduction of compliant medical devices.
The medical device industry is entering its most significant period of regulatory change since the 1990s. While the new regulatory landscape will bring complex challenges for manufacturers, it will also introduce essential changes designed to enhance patient safety and enable the introduction of more innovative medical device solutions.
Why work with us?
We recognise that every organisation is unique, and we understand that the impact of the new medical device regulations will depend on the complexity of your organisation. We take the time to understand your organisation, using analytical precision to achieve the best outcomes for you and your clients.
Our assessors are experts in the medical sector and through their participation in technical committees they have actively shaped the Medical and In Vitro Diagnostic Device Regulations and harmonised standards.
We specialise in management systems compliance including gap analysis, assessment and certification, all underpinned with expert advice designed to meet the needs of your industry.
We explore every problem thoroughly with exact, analytical precision. We leave no stone unturned and no questions unanswered.
We provide practical client training courses worldwide in various languages, led by trained and qualified tutors. Many of our courses are endorsed by relevant professional bodies and based on our experience of assessing management systems. We offer both public and in-house training services including customised training solutions.
Don’t let your certification journey stop with quality; at LR, we deliver certification, validation and verification assessment services to all of the world’s leading standards and schemes including health and safety, environmental, sustainability, energy management, business continuity, cyber security and many more.
Independent & Impartial
We maintain our independence and impartiality by pro-actively managing conflicts of interest across all LR businesses including those which may exist between consultancy and third-party certification services. We will not offer consultancy services for any management system that is in the process of or has completed accredited third-party certification with LR. Further, if we are already providing consultancy services relating to a management system, we will not offer any accredited third-party assessment services.
How we can help
From CE Marking through to ISO 13485 certification, LR can help.
Who we work with
We help thousands of organisations, from the world's best known brands to the smallest of suppliers. How can we help you?
Our latest updates
US FDA announces plans to use ISO 13485 for medical devices regulation
LR achieves global accreditation for 'Parts & Services' for ISO 13485:2016
Join us at these forthcoming events
15 Nov 18
Cyber Security Summit & Expo
London, United Kingdom