The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. Our internal audit services for MDSAP include:

• offer comprehensive guidance on meeting the regulatory requirements of the MDSAP participating countries (Australia, Brazil, Canada, Japan, and the United States).This includes helping organizations understand and interpret the specific regulations and standards that apply to their medical devices in each jurisdiction,
• assist in preparing for MDSAP audits by reviewing documentation, and providing training for staff,
• help develop, implement, and improve a robust QMS that complies with the MDSAP requirements. This involves creating and refining procedures, processes and documentation that enhance quality control, risk management, and regulatory compliance throughout the product lifecycle.
• providing specialized training programs to ensure that all relevant personnel are knowledgeable about MDSAP requirements and standards. This includes training on internal auditing, regulatory updates, risk management, and continuous improvement practices.