Gain certification for ISO 13485.
ISO 13485 certification services from LRQA 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.
ISO 13485 CERTIFICATION SERVICE
Remote Audit
Using secure remote technology, we deliver the same high-quality audit services that were previously only available as on-site audit. Our audit services will consist of a blend of remote and on-site audit activities providing you with an unrivalled level of insight and expertise.
Gap analysis
LRQA’s ISO 13485 gap analysis is an auditor-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. Download our ISO 13485 gap analysis factsheet.
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.
LRQA auditors 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. LRQA provides certification, validation and verification services against leading international standards that focus on health and safety, environmental, sustainability, energy management, cyber security and more.