ISO 13485:2016

Medical Devices

ISO 13485:2016 Medical Devices Quality Management Training & Certification Services in the UK

Ensure compliance and quality in the medical device industry. We offer expert-led ISO 13485:2016 Training and Certification Services across the UK, supporting manufacturers and suppliers in meeting regulatory and customer requirements.

What is ISO 13485:2016?

ISO 13485:2016 is the internationally recognised standard for Quality Management Systems specific to the medical device industry. It ensures the consistent design, development, production, and delivery of medical devices that meet regulatory standards.

Our Services

✅ ISO 13485:2016 Training (Onsite & Online)

Awareness Training – Overview of ISO 13485 requirements
Internal Auditor Training – Perform QMS audits within medical device firms
Lead Auditor Training – Get certified as a lead auditor in ISO 13485
Implementation Training – Understand and align with ISO 13485 standards

Courses are delivered by experts with sector-specific experience.

✅ ISO 13485:2016 Certification Services

We coordinate with accredited third-party certification bodies to facilitate your ISO 13485 certification.

Our services include:

ISO 13485 Readiness & Awareness Materials
Training Support for Audit Preparation
Liaison with Accredited Certification Bodies

Note: We do not offer consulting services. Certification is provided by recognised third-party bodies.

✅ Why Choose Us?

✔ Industry-Focused Medical Device QMS Training
✔ Professional Trainers with Healthcare Experience
✔ Practical Guidance and Flexible Scheduling
✔ Strong Network of Accredited Bodies

✅ Who Needs ISO 13485 Certification?

Medical Device Manufacturers
Contract Manufacturers
Suppliers & Distributors
Diagnostic Labs
Regulatory Bodies & Healthcare Providers

✅ Benefits of ISO 13485:2016 Certification

Ensure product safety and compliance
Access global markets
Improve process efficiency
Reduce product recalls and risks
Demonstrate regulatory competence

Get Started Today

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ISO 13485 is the world’s most recognised quality management standard used by millions of organizations all over the world to continuously improves performance. By becoming certified your organisation by KRISHTECH is making a statement about your commitment to continually and consistently meet the expectations of your customers through the improved efficiency and effectiveness of your business processes