Workshops
Effective compliance depends not only on procedures and documentation but also on the competence and confidence of the people who implement them. Under the MDR and IVDR, regulatory expectations have evolved beyond written systems. Organisations must demonstrate that their personnel are trained, competent, and capable of applying regulatory and quality principles in daily operations. Yet many companies, particularly small and mid-sized manufacturers, struggle to maintain consistent internal expertise as regulations evolve and teams expand. Structured, relevant, and well-delivered training is therefore essential to achieving and sustaining compliance maturity.
Our Workshops are designed to build this internal capability through focused, interactive learning delivered by experienced consultants and former regulators. Each session is tailored to the client’s organisational profile, product portfolio, and regulatory objectives. We ensure that participants not only understand the legal and procedural requirements but can apply them effectively within their own operational environment.
Training topics span the full spectrum of medical device and IVD regulatory affairs and quality management. Core modules include MDR and IVDR fundamentals, technical documentation structure, risk management, post-market surveillance, vigilance reporting, and quality system implementation under ISO 13485. For more advanced teams, we deliver specialised sessions on areas such as clinical evaluation, EUDAMED and UDI operations, labelling compliance, SaMD and AI regulation, and market access alignment. Each module is continuously updated to reflect the latest MDCG guidance, harmonised standards, and regulator expectations.
Workshops are conducted in interactive formats that combine structured instruction with practical exercises and real-world case studies. Participants engage in document reviews, mock audits, and scenario-based problem solving designed to simulate actual regulatory challenges. This experiential approach reinforces learning, promotes collaboration between departments, and improves knowledge retention far beyond traditional classroom training.
We also assist organisations in developing internal training frameworks that ensure continuous competence management. This includes defining training matrices, maintaining training records within the QMS, and establishing periodic refresher programs. These frameworks provide verifiable evidence of competence during audits and regulatory inspections, reducing findings and strengthening overall system integrity.
Training can be delivered onsite, remotely, or through hybrid formats, accommodating the operational needs of both local and multinational teams. Each engagement concludes with participant evaluations and optional follow-up assessments to measure knowledge transfer and identify further development areas.
Our Workshops are designed to transform regulatory complexity into organisational competence. By equipping teams with the understanding and tools necessary to navigate MDR, IVDR, and ISO 13485 requirements, we help clients build a sustainable foundation for long-term compliance and operational excellence.
For further information or to arrange a customised workshop program, please contact our training and compliance development team.
