NSF International provides regulatory and quality medical device training courses and professional qualifications. Its courses are highly interactive and based on real scenarios, helping you meet international requirements throughout the product lifecycle.
The company offers public training classes and private in-house courses. Its industry and regulatory experts work with you to deliver flexible, modular, and professionally accredited training.
Public courses include:
Quality management systems lead auditor training for ISO 13485:2016 and MDSAP
This five-day medical device auditor training programme is the first of its kind to incorporate medical device and single audit programme (MDSAP) requirements, and is certified by the Chartered Quality Institute (CQI) / International Register of Certificated Auditors (IRCA).
During the course, you will plan and prepare audits based upon case studies that simulate both supplier and third-party audits utilising the MDSAP audit requirements.
Throughout the course, you will participate in simulated auditing exercises that include planning, preparation, and evaluation of audit evidence. You will also practice the application of ISO 13845:2016 and the MDSAP requirements.
This training course will help you:
- Plan, conduct, report, and follow up on a QMS audit in accordance with ISO 19011, ISO 13485:2016, and MDSAP
- Apply the MDSAP audit strategies adopted by auditing organisations in the MDSAP programme
- Identify nonconformities, grade nonconformities, and prepare an audit report in accordance with the MDSAP criteria
ISO 13485:2016, MDSAP requirements, and regulatory transitions
ISO 13485 is the international standard that defines quality management system requirements for organisations involved in one or more stages of the medical device product lifecycle.
This includes design and development, production, storage, and distribution, as well as installation or servicing of a medical device. ISO 13485:2016 can also be used by suppliers or external parties that provide product and quality management system-related services.
The MDSAP audit process was designed to provide a single audit that covers regulatory requirements of medical devices, QMS, and regulatory purposes (ISO 13485), as well as the specific requirements of medical device regulatory authorities participating in the MDSAP (Australia, Brazil, Canada, Japan, and the US quality system regulation).
This course offers practical instruction on both ISO 13485:2016 and MDSAP, preparing you and your organisation for the challenges of implanting these requirements and preparing for successful audit outcomes associated with these standards and policies.
European Medical Device Regulations (EU MDR) strategic planning for the coming changes
The European regulatory landscape has changed, becoming more stringent and technically challenging for medical device companies. With major changes to notified body activities, device classification, clinical data requirements, post-market surveillance, conformity assessment, and technical documentation, companies will need to plan carefully to ensure they understand the requirements and have the appropriate data, processes and resources in place.
This two-day course examines the new EU medical device regulations, outlines the major changes that industry will need to be prepared to address, and provides insight into the impact upon medical device companies and the steps they can take to navigate the new regulatory environment.
The NSF EU MDR course includes assessments to ensure that the student has achieved the knowledge and understanding to effectively plan for the new EU regulation, enabling you and your organization to feel confident that you can implement the forthcoming changes.
This course provides a certificate of successful completion, demonstrating that your knowledge has been evaluated.