OSA regulatory expert Mathias Semombwe will be available to provide dedicated regulatory support to members at 100% Optical: 28 February to 2 March, Excel London.
As Quality and Regulatory Affairs Manager, Mathias will be on the OSA stand offering practical guidance on regulatory compliance and medical device requirements affecting optical businesses operating in the UK and EU.
Support will cover key requirements for placing medical devices on the market under EU MDR and UK MDR, including device qualification and classification, CE and UKCA marking, preparation of compliant technical documentation, and implementation of Quality Management Systems in line with ISO 13485. Guidance will also include device registration requirements, as well as post-market surveillance and vigilance obligations to ensure ongoing compliance.
Mathias Semombwe encouraged OSA members to engage:
“Regulatory requirements for medical devices continue to evolve, and it is important that optical businesses understand their obligations. Larger organisations often have dedicated regulatory teams, but smaller companies may not have the same resources. The OSA is pleased to provide accessible, expert support to help members navigate compliance requirements and maintain market access with confidence.”
OSA encourages members to visit the stand to discuss their regulatory questions and ensure they are prepared for current and future regulatory requirements.