MDSAP Mock Audit and Training

Training and mock audits for compliance under MDSAP

MDSAP has evolved into one of the world’s essential regulatory programs through which manufacturers secure market access. Having insight into the minds of the jurisdictional regulators is beneficial to any company’s regulatory pathway.  With former notified body leaders who helped develop the MDSAP audit process on staff, an AlvaMed mock audit/inspection will prepare you for the real thing. Clarify requirements for compliance under MDSAP for all five participating jurisdictions and give your staff confidence with expert training from AlvaMed.

MDSAP can offer access to multiple jurisdictional areas, so it’s essential to plan accordingly. Ensuring your needs for market access are understood allows the audit/inspection process to achieve those goals.

Learning about your organizational structure is essential to getting the most out of a mock audit.  AlvaMed works with your team to focus on areas you’ve identified as needing attention.  Learning the MDSAP process is also beneficial to the employees so they can ‘think like a regulator’.

Audits can be conducted to best suit your organization. A true mock audit can be unannounced to mimic that real third-party approach, or they can be collaborative to keep employees engaged. Regardless, the idea is to benefit from the exercise and grow as an organization.

The results of all audits are recorded in an audit report which is supplied to the organization’s management and shared with the employees. Unlike a regulator’s audit, AlvaMed will guide your organization through the results to ensure a full understanding.

If assistance is required in remediating audit results, AlvaMed is here to help. Whether it involves process improvements, corrective actions for nonconformities, or addressing additional training needs, our staff is well-equipped to provide support.

AlvaMed’s experts have the regulatory competence to serve your needs.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

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MDSAP Mock Audit and Training FAQ's

No. The MDSAP Audit Approach was developed to cover existing requirements from the Regulatory Authorities participating in the MDSAP. The program does not add any new requirements to existing requirements from ISO 13485 or other country-specific requirements of the participating Regulatory Authorities.

The regulatory requirements of the participating Regulatory Authorities have been incorporated into the MDSAP Audit Approach. An auditing organization will perform audits using this approach and record findings in relation to the regulations of the participating Regulatory Authorities. Each Regulatory Authority independently utilizes the MDSAP audit deliverables (audit reports, certification documents) according to their regulations and policies.

The “Initial” audit also known as an “Initial Certification” audit consists of a Stage 1 and a Stage 2 audit.

  • Stage 1 – A first Stage 1 audit consists of a documentation review and the evaluation of the readiness of the manufacturer to undergo a Stage 2 audit.
  • Stage 2 – The purpose of a Stage 2 audit is to determine if all applicable QMS requirements of ISO 13485 and all other applicable regulatory requirements from participating regulatory authorities have been effectively implemented.

With a deep understanding of the MDSAP requirements, the AlvaMed team can equip your team with the knowledge and skills necessary to navigate MDSAP with confidence.  Our expert team can provide guidance on how to translate requirements into your existing quality management systems (QMS).  Training delves into the practicalities of the MDSAP audit, including scheduling procedures, documentation expectations, and auditor interactions. This equips teams to navigate the audit with confidence and minimize disruptions.

Brian Ludovico

Director of Quality Affairs

Ready to learn more about how AlvaMed can manage your mock-audit or how MDSAP training can pave the way for a smoother regulatory journey?

Schedule time to meet with Brian Ludovico.