Sancert is an accredited certification body, offering internationally recognised ISO 13485:2016 Medical Device Quality Management System certification. We are accredited by SANAS (South African National Accreditation Services) and are recognised by SAHPRA (South African Health Products Regulatory Authority) as a Conformity Assessment Body (CAB), ensuring credibility and compliance with international medical device regulations.
Benefit from our internationally recognised expertise and accreditations.
Streamline your compliance efforts with our user-friendly online platform.
Rely on our ongoing support and guidance for sustained compliance.
Stage 1
Before your formal certification audit, we conduct a comprehensive gap audit to assess your current QMS against ISO 13485:2016 requirements. You’ll receive a detailed report outlining areas meeting requirement and any noncompliance areas, giving you time to refine your system before the stage 2 final certification audit. Clarity on requirement is important, and we ensure our clients are well up to speed allowing for a documented ISO13485:2016 QMS that adds value for your company.
Stage 2
Once your system is aligned with ISO 13485:2016, we perform the official Stage 2 final certification audit. Upon successful completion, you receive your accredited certification, demonstrating compliance with international medical device quality standards.
Sancert have registered Auditors locally allowing for travel costs to be significantly reduced.
Meet SAHPRA and international medical device regulations.
Expand into global markets with an internationally recognised certification.
Ensure product consistency, safety, and effectiveness.
Stand out in the medical device industry with accredited certification.
Sancert is committed to providing an efficient, transparent, and professional
certification process. With quick turnaround times and expert auditors, we help you
achieve ISO 13485:2016 certification without unnecessary delays.