Managing Competence within the Medical Device Industry
Many medical device developers and manufacturers rely heavily on the competence of their staff to achieve their business goals. Like many companies, particularly in the start-up phase, it can be a daunting task to know where to start with documenting the necessary evidence to demonstrate that competence to third parties such as investors and notified or approved bodies.
Under the MDR / IVDR, the requirement to have a Person Responsible for Regulatory Compliance brings the need to demonstrate competence into even sharper focus.
This webinar has been developed to help you understand the ‘big picture’ of competence management from selection of the right competencies for success to maintenance of collective organisational knowledge.
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Suitability - Who should attend?
Benefits of Attending
Through attendance on this course, delegates will be able to:
- Identify the competencies required for the growth of the company
- Plan recruitment effectively to deliver competency
- Utilise performance reviews to manage competency
- Document the right information as evidence of competence
This will enhance the company’s ability to meet the competence-related requirements of ISO 9001:2015 clauses 7.1.6 and 7.2, ISO 13485:2016 clause 6.2 and regulatory requirements of Article 15 in MDR / IVDR Person Responsible for Regulatory Compliance (PRRC).
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