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.
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.
We want to express our sincere appreciation for AlvaMed’s outstanding support throughout our MDSAP and CAPA project. With AlvaMed by our side, we not only achieved regulatory adherence but also fortified our quality management systems. AlvaMed’s partnership has been transformative, and we recommend their services to anyone seeking a smooth pathway through the medical device regulatory requirements.
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
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.
Ready to learn more about how AlvaMed can manage your mock-audit?
Schedule time to meet with Brian Ludovico.
