We support medical device manufacturers in implementing a Quality Management System (QMS) compliant with the Medical Device Single Audit Program (MDSAP) requirements through the following services:

• Gap Analysis: Evaluating your QMS against MDSAP requirements to identify compliance gaps.
• QMS Design and Implementation: Developing or upgrading your QMS to align with the ISO 13485 standard and country-specific regulations covered under MDSAP (Australia, Brazil, Canada, Japan, and the US) to meet MDSAP requirements.
• Documentation Support: Preparing and optimizing policies, procedures, and records to meet MDSAP audit criteria.
• Audit Preparation: Providing training and conducting internal audits to ensure your readiness for MDSAP certification audits.
• Post-Audit Support: Assisting with non-conformance resolution and closing the probable non-conformities to obtain the certificate.

Our expertise ensures a seamless implementation of an MDSAP-compliant QMS, enabling efficient regulatory approval across multiple jurisdictions.

We offer comprehensive consulting services to help manufacturers integrate the Medical Device Single Audit Program (MDSAP) with EU MDR compliance, ensuring streamlined processes and dual regulatory alignment. Our services include:

• Integrated Gap Analysis: Assessing your Quality Management System (QMS) to identify gaps for both MDSAP and EU MDR requirements.
• Unified QMS Development: Designing a single QMS framework that aligns with ISO 13485, MDSAP country-specific regulations, and EU MDR requirements, reducing redundancies.
• Documentation Harmonization: Preparing and aligning Quality Manual, Documented procedures and SOPs, forms and all required documentation including technical files.
• Audit Preparation: Training your team for MDSAP audits and EU MDR notified body assessments, ensuring efficient and successful outcomes.
• Post-Audit Support: Assisting with non-conformance resolution and closing the probable non-conformities to obtain the certificates.

Our expertise ensures a cohesive approach to meeting these complex regulatory frameworks, saving time and resources while ensuring global market access.

We offer comprehensive Quality Management System (QMS) maintenance services to support medical device manufacturers in achieving ongoing compliance with regulatory requirements, including:

QMS Maintenance for Surveillance Audits

• Documentation Updates: Keeping policies, procedures, and records aligned with the latest regulatory standards (e.g., ISO 13485, MDSAP, EU MDR).
• Audit Readiness: Ensuring your QMS remains compliant and prepared for surveillance audits by notified bodies or regulatory authorities.

Outsourced Internal Audits

• Regular Internal Audits: Conducting scheduled audits to evaluate the effectiveness of your QMS and identify areas for improvement.

Benefits of Outsourcing to Us

• Cost-Effective Solutions: Reduce the need for in-house resources while maintaining a high standard of compliance.
• Expert Guidance: Access professional expertise with in-depth knowledge of global regulations.
• Focus on Core Activities: Free up your team to focus on innovation and operations, while we ensure compliance.

Our services ensure your QMS remains robust, efficient, and ready for regulatory inspections, helping you minimize costs and maximize compliance confidence