ISO 13485:2016, Medical Device Regulatory, Quality Management System Training and Transition Support
Manufacturers of medical devices other than Class I must comply with the Quality Management System (QMS) standard ISO 13485. The latest version of the standard is 2016 and medical device regulators will enforce its compliance by 31 March 2019. The updated standard (ISO 13485:2016) has a stronger emphasis on customer, risk and regulatory requirements.
KD&A offers the following training programs to assist your organisation with the development and understanding of the QMS and/or its transition to the updated standard.
Transition to ISO 13485:2016 – Established medical device manufacturer
ISO 13485:2016 – For start-up medical device organisations
General QMS training and support
Please find below detail on more common and suggested training format, this can be modified to best suit your organisation:
1. Module 1 – Training needs analysis
- Onsite review of Quality Assurance (QA) roles and responsibilities with regards to the QMS.
- Interview QA and other key personnel to determine knowledge/skill level and training needs.
2. Module 2 – ISO 13485:2016 training and transition planning
- On-site tailored training for QA, Regulatory Affairs (RA) and key personnel for up to 15 people, including:
- MS and medical device regulatory fundamentals.
- Tailored training workshops based on review of existing procedures, identification of gaps and transition planning.
- Mentoring to support a smooth transition.
Please contact KD&A for detail on our fees, and avoid market entry delays, potential issues with medical device regulators and ongoing supply risks.