LRQA Ltd
Hiramford, Middlemarch Office Park, | Siskin Drive
Coventry, CV3 4FJ UK
Tel: +44 (0) 800 783 2179
Web: Click here for the site
Key Contacts
Marie Baker, Senior Marketing Officer
Debbie East-Nuttall, Medical Device Account Manager
Mark Dougan, UK & Ireland Sales & Marketing Manager
Positioning Statement
With more than 10 years’ experience as a notified body, LRQA has established an in-depth knowledge and understanding of medical directives.
We are one of the most respected bodies providing services under the Medical Device Directive (93/42/EC) and In-vitro Diagnostic Directive (98/79/EC) to major organisations around the world.
Additionally, LRQA also provides certification services to the international quality standard ISO 13485, which is aimed at clients who manufacture medical devices or produce components for medical device organisations.
Our ‘Business Assurance’ approach will support your business priorities. We go beyond compliance and get to the heart of your business process.
Company Profile
LRQA – Your Route to Conformity
Who we are?
Formed in 1985 to offer independent certification of management systems, LRQA is part of the Lloyd’s Register Group.
UKAS-accredited, LRQA has been involved in creating global standards and processes that enable you to make a real, measurable difference to your organisation.
We are also notified body for Medical and In-vitro Diagnostics Devices under the relevant Directives and with more than 10 years’ industry experience we are ideally placed to meet your regulatory requirements.
What do we do?
LRQA offers independent, impartial third-party verification and certification services to a variety of international standards. And over 10 years’ ago we became a designated notified body to provide product conformity assessment services under the Medical Device Directive (93/42/EC) and In-vitro Diagnostic Directive (98/79/EC).
We do this by providing a person or team of people to review, test and inspect aspects of your product. We can also provide a person or team of people to verify aspects of your quality management system against ISO 13485.
Our experts provide an impartial, balanced view of how closely you are meeting your legal objectives. Typically, this will be in the form of a report including an executive summary tailored to your precise set of circumstances.
ISO 13485
Based on the Quality Management System standard ISO 9001; ISO 13485 defines quality management system requirements for manufacturers of medical devices. The primary objective of the standard is to promote harmonisation of regulatory requirements for manufacturers of medical devices on an international scale.
LRQA has over 20 years’ experience of auditing organisations’ to ISO 9001 and we have developed a unique insight into helping a wide range of organisations’ around the world.
Medical Device Directive
Devices covered by the MDD are group into four classes according to the level of risk they present. The classification determines the choice of conformity assessment available to you.
| Class |
Generally regarded as |
| Class I |
Low risk |
| Class IIa |
Medium - Low risk |
| Class IIb |
Medium - High risk |
| Class III |
High risk |
Under the MDD 93/42/EEC, LRQA is designated by the Medicines and Healthcare Products Regulatory Agency (MHRA) to provide conformity assessment for CE marking for all types of devices requiring notified body assessment.
In Vitro Diagnostic (IVD) Devices Directive
Covers devices used in vitro for the examination of a specimen derived from the human body, including reagents, instruments and specimen receptacles.
Under the IVD Directive, LRQA is designated by the MHRA for the full range of devices. We are able to offer conformity assessment activities for the highest risk devices in List A.
Business Assurance Approach
Our service delivery is shaped by our ‘Business Assurance’ philosophy which is our own unique approach to product reviews and testing, plus management system assessment.
We have a dedicated medical team that comprises of both technical and operational support staff who are committed to providing a streamlined, ‘one-stop-shop’ service to help clients meet their legislative requirements.
Our technical staff are experts in their field, meaning we are in an ideal position to offer informed and practical advice. And this is why many organisations, world-wide, choose LRQA as their service provider.
Expertise • Knowledge and awareness of all EU regulations
• Unsurpassed technical knowledge
• Class lll accreditation for high risk products
• Medical/science trained assessors
Services • Notified Body Services for . . .
• Medical Devices Directive
• In Vitro Diagnostics
• ISO 13485:2003
• Canadian Health Scheme
Clients
Abbott
GE Healthcare
William Cook Europe
PALL Medical
Roche Diagnostics
Geographical Coverage
Global
|
|
|
|
LRQA Ltd
Hiramford, Middlemarch Office Park, Coventry |
|