Available Services

   - Guidance on regulatory submissions (e.g., 510(k), PMA, CE marking).

   - Interpretation of regulatory requirements and standards.

   - Assistance with interactions with regulatory agencies (FDA, EMA, etc.).

   - Preparation for audits and inspections.

 - Assisting in establishing design controls throughout the product development lifecycle.

   - Conducting design reviews and ensuring verification and validation activities are conducted.

   - Documentation of design inputs, outputs, and changes.

Quality Management System (QMS) 

   - Design and implementation of a QMS compliant with ISO 13485 and other relevant standards.

   - Development of standard operating procedures (SOPs).

   - Facilitation of quality system documentation, including quality manuals and policies.

 - Developing tailored training programs for staff on quality assurance, regulatory requirements, and best practices.

   - Conducting workshops and seminars on specific quality topics related to the medical device industry.

- Conducting risk assessments and developing risk management plans compliant with ISO 14971.

   - Performing Failure Mode and Effects Analysis (FMEA) to identify potential risks.

   - Ongoing monitoring and management of risk throughout the device lifecycle.

  - Establishing post-market surveillance systems for ongoing monitoring of device performance.

   - Assisting in the collection and analysis of product feedback.

   - Development of processes for handling adverse event reporting and corrective actions.