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.
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.
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.