MDSAP Support

Embark on a seamless journey to compliance within Canada’s medical devices market with our specialized MDSAP gap analysis and implementation support services, now including comprehensive guidance towards achieving MDSAP certification. Tailored for manufacturers navigating the intricate landscape of medical device regulations, our offerings are designed to demystify the complexities of compliance, ensuring your products meet Canada’s esteemed quality and safety standards.

MDSAP Gap Analysis: Your Roadmap to Compliance

Our comprehensive MDSAP gap analysis service is the first step toward ensuring your medical devices align with the Medical Device Single Audit Program (MDSAP) requirements, paving the way for certification. This critical evaluation serves as a diagnostic tool, identifying any discrepancies between your current quality management system and the rigorous standards set by Health Canada under the Medical Devices Regulations (SOR/98-282).

Customized Implementation Support: From Analysis to Certification

Following the gap analysis, our team provides bespoke implementation support, guiding you through the necessary adjustments to bridge identified compliance gaps and move closer to MDSAP certification. This includes:

  • Tailored advice on enhancing your quality management system to align with MDSAP requirements.
  • Assistance in preparing and organizing documentation that demonstrates compliance with Health Canada’s regulations.
  • Guidance through the MDSAP audit process, ensuring your organization is well-prepared and confident.

Achieve MDSAP Certification with Confidence

Achieving MDSAP certification is a significant milestone for any medical device manufacturer aiming to enter or maintain their presence in the Canadian market. Our services extend beyond gap analysis and implementation support to include:

  • Detailed preparations for the MDSAP audit, from initial readiness assessment to post-audit follow-up.
  • Strategies to effectively address and correct any audit findings.
  • Ongoing support to maintain MDSAP certification and adapt to any regulatory changes.

Your Partner in Navigating Regulatory Hurdles

By partnering with us, you gain access to expert insights, a clear, actionable plan for MDSAP certification, and the peace of mind that comes from knowing your regulatory compliance is in expert hands. Our service is designed for innovators and manufacturers at all stages of product development, committed to ensuring your medical devices contribute to health and well-being across Canada.

Why do you need this service?

The conduction of internal audits will shed light into your existing compliance status. This helps to define the exact resources need to close these gaps.

Our experts will support in implementing the required measures to comply with key regulations. Independent if you already have already an existing quality certificate. We adapt to what is actually required. You invest only what is really needed.

You talk with your competent authority and don't understand what they are requiring? Our experts, with many years of equivalent experience, can help. We speak the language both sides can understand.

Looking for MDSAP assistance?

Ensure your Quality Management System is fully compliant. Our team of experts conducts comprehensive internal audits, identifies gaps, and implements essential changes, making the compliance process seamless for you. We even assist with challenging conversations with competent authorities. Why wait?

Partner with Sobel Consultancy and make your journey a successful one.

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