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ISO 13485 Certification Services

Gain confidence with ISO 13485 certification.

ISO 13485 certification services from Lloyd’s Register (LR) support your journey towards local and international compliance. We work closely with manufacturers to determine the best process for certification and whether any other assessments are applicable given regional regulatory requirements.

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Gap analysis

LR’s ISO 13485 gap analysis is an assessor-led service that reports on your readiness to implement the standard, helping you understand how your existing quality management system addresses, or needs to address, updates introduced by ISO 13485:2016.

Certification and assessment

The primary objective of the ISO 13485 certification process is to ensure medical devices consistently meet customer needs and applicable regulatory requirements.

LR assessors specialise in medical device compliance, employing an ISO 13485 audit to simplify both assessments and final certification. Our expertise reflects the needs of your organisation through a tailored approach providing a holistic evaluation that considers both local and international requirements.

Integrated assessment

If your organisation has multiple management systems across quality, environmental, occupational health and safety, business continuity management and information security management, you could benefit from a coordinated evaluation and surveillance programme, reducing costs and avoiding duplication of effort.

Assurance services

Your certification journey doesn’t have to stop with ISO 13485. LR provides certification, validation and verification services against leading international standards that focus on health and safety, environmental performance, sustainability, energy management, cybersecurity and more.

Impartiality

We maintain our impartiality by proactively managing conflicts of interest across all LR businesses including those which may exist between consultancy and third-party certification services. Click here to learn more

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