Medical Device Design And Development Services

• Quality Management Systems (QMS): Implement and maintain robust QMS in accordance with ISO 13485 standards to ensure consistent product quality.
• Risk Management: Conduct thorough risk assessments and implement mitigation strategies as per ISO 14971 guidelines.
• Process Validation: Validate manufacturing processes to ensure consistent and reliable results.

Post-Brexit, the UK has established its own regulatory framework:

• Regulatory Strategy: Develop a tailored regulatory strategy for your target markets.
• Submission Preparation:Prepare and submit regulatory documentation to agencies such as the MHRA, European Commission, FDA and other global agencies.
• Post-Market Surveillance: Monitor device performance and ensure ongoing compliance with regulatory requirements.

Establish and maintain design controls throughout the development process to ensure that all design inputs and outputs are thoroughly documented and verified.

• Design History File (DHF): Establishing and maintaining a DHF to document the design process and demonstrate compliance with regulatory standards.
• Verification and Validation:Implementing verification and validation activities to confirm that design specifications are met and that the device performs as intended.