Regulatory Guidance and Advice

Our experienced team can assist you with in the following services:

• CE and UKCA Marking Guidance.
• Technical File Preparation and Reviews.
• Medical Risk Assessment Preparation – in accordance with ISO14971:2019.
• Guidance on MDR Compliance - against the MDR directive (EU) 2017/745.
• Guidance on Compliance against the UK Medical Devices Regulations (UK MDR) 2002.
• Pre-Compliance Reviews - on product design for EMC and safety.
• Documentation Preparation and Guidance - for Pre-Market Notification FDA 510(k) submissions.
• Technical Documentation and Marking Guidance - for medical and electrical devices.
• Assistance from development through to final product evaluations.