The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer’s Quality Management System (QMS), which satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO), which are authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements.
MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.
BAI has a proven track record of success in helping medical device companies comply with MDSAP. Our team of experts have in-depth knowledge of MDSAP and the relevant regulatory requirements.
• Review & understanding of the QMS Scope, Company information and device-specific technical information like Intended Use, Device description, Model and variant details, device classification Critical Suppliers etc.
• Gap Analysis
• Establishing Technical Documentation as per applicable standard and regulatory requirements of medical device markets: Australia, Brazil, Canada, Japan and the United States.
• Design and develop QMS processes and procedures aligned with MDSAP approach, the organization's business objectives and compliance requirements.
• Develop and deliver awareness programs for employees.
• Provide specialized training for QARA individuals responsible for implementing controls.
• Promote a culture of quality within the organization.
• Provide support during implementation of QMS controls and measures to meet MDSAP requirements.
• Handhold wherever required.
• Internal implementation reviews and readiness.
• End-to-end support right from selection of AO till the achievement of Certification.
• Trainings, Audits & Technical guidance
• Regular risk assessments, audits, and updates to QMS processes and procedures
• Technical guidance on Registering Devices in specific markets.
We are passionate about our work and how it translates into Return on Investment for our valued partners
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