LRQA - Medical Device Assessment, Certification and Verification

LRQA is one of the world’s foremost management system certification, verification and training organisations. We offer assessment, registration and certification services to the global medical device industry.

We are committed to helping clients obtain the maximum business benefit from their management systems and processes. This commitment is represented by our business assurance service portfolio. Through business assurance we provide insightful, challenging, yet realistic assessments of organisations.

Our distinctive business assurance approach demonstrates our in-depth understanding of what management systems are really about. LRQA assessments bring increased certainty to your business.

LRQA’S MEDICAL DEVICE ASSESSORS

LRQA employs medical device assessors from within the medical device industry. Assessors are appointed for their excellent qualifications, experience and training in global medical device quality and regulatory requirements. Once appointed, they undertake further extensive training with LRQA to ensure the highest level of consistency and quality in the delivery of our services.

MEDICAL DEVICE ASSESSMENT SERVICES

LRQA provides a wide range of assessment, registration, and certification services in support of global medical device industry requirements. Key services include:

• EU notified body (CE marking) services: In Vitro Diagnostics Directive (98/79/EC) and Medical Devices Directive (93/42/EEC)
• Management system assessment services: ISO 9001, ISO 13485, ISO 14001 and Canadian recognized registration (CMDCAS / ISO 13485 recognized registrar)

WHY CHOOSE LRQA?

Business assurance - unique to the certification and verification industry, Business assurance takes assessment beyond mere compliance with standards. Business assurance looks at how an organisation’s systems and processes deliver its business objectives. This makes businesses more efficient and competitive

Reputation and experience - LRQA is globally recognised and respected for our high standards of technical competence, impartiality and independence. LRQA has certified more than 26,000 organisations around the world in a wide range of industries

Global capabilities - we offer assessments in over 30 languages from our global network of offices

Assessment methodology - LRQA assessments provide ongoing support and verification of continual improvement, effectiveness and suitability in areas that support your declared business, quality and compliance related goals

Assessor expertise - LRQA assessors are experienced and highly competent in their fields of expertise. LRQA utilises a planning process that ensures your assessor will have the appropriate background and expertise in your industry and be able to conduct an effective and robust assessment of your systems

LRQA’s team of expert assessors, technical staff and worldwide network of offices are ideally suited to meet your organisation’s management system and assessment needs for current and emerging regulations. Contact us to find out more.

For more information please visit our website at www.lr.org.

For contact details of our regional offices please follow the regional offices link.