Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
RegPro Medical
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MDSAP
The Medical Device Single-Audit Program unites QMS assessment for five key markets under one auditing program. Regulatory authorities in USA, Australia, Canada, Brazil, and Japan have agreed to accept the MDSAP certification, based on ISO 13485, as an alternative to auditing or inspection by the respective government agencies. MDSAP certification is currently required for medical device licensing in Canada and is optional in the other four jurisdictions. To achieve MDSAP certification, Manufacturers contract with one of fifteen authorized Auditing Organizations to perform an audit and issue a certificate covering the regulatory requirements of each of the five countries. Annual surveillance audits and three-year re-certification audits are performed, as with most ISO 13485 certifications. Preparing for an initial MDSAP certification audit may include establishment of a full ISO 13485 QMS if you are not previously certified or could only require an upgrade to add the detailed specific extra requirements of MDSAP.
*As reported by MedTech Europe
What will RegPro Medical Do?
RegPro Medical will help you select an accredited MDSAP Auditing Organization that meets your needs and criteria, coordinate your application and initial audit, and facilitate your response and follow-up for any audit findings. If you are in a startup stage RegPro Medical will establish, implement, or update your ISO 13485 Quality Management System to meet the regulatory requirements and tailored to the unique aspects of your design and operations. If you are already certified to ISO 13485, we will review your current QMS and add the detailed MDSAP requirements and guide you through the audit and certification process.