On-Site Medical Device Single Audit Program (MDSAP) Training for Manufacturers

ANSWERED ON THIS PAGE:

• What does our quality team need to know about the MDSAP to participate in the program?
• Which quality documents and procedures should we update to prepare for MDSAP certification?
• Is there a cost-effective way to learn about the MDSAP system?

The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to meet regulatory and quality system requirements in multiple markets through a single audit. Current MDSAP members include Australia, Brazil, Canada, Japan, and the United States, and others are expected to join as the program matures.

MDSAP will be required by Health Canada starting January 1, 2019, which is motivating more manufacturers to adopt the program. Emergo’s MDSAP training will help you understand the requirements, audit considerations, and country-specific details you need to consider to have a successful MDSAP audit.

MDSAP training: Key learnings and objectives

Our in-depth training dives into the specific requirements of the MDSAP. Your team will learn what it takes to revise internal documentation to refer to applicable MDSAP requirements, add or revise procedures that address specific regulatory requirements in participating countries, and much more, including:

• Key terms in the MDSAP process
• Program objectives
• Key players, including participating countries, regulatory bodies, and auditing organizations
• Country-specific QMS requirements under the MDSAP
• How to plan and prepare for an MDSAP audit
• How to interpret an MDSAP audit report

The country-specific portion of the training is customized to your target markets and the classification of your product(s).

Effective on-site MDSAP QMS training for your employees

Compared to hotel-based classes or online training, our MDSAP awareness training is an excellent value for companies training three or more employees at a time. The training is conducted at your facility by senior quality consultants who spend most of their time helping device companies implement quality systems, not jumping from city to city doing training. As such they are fully tuned in to the needs of the industry. A private, on-site venue allows your employees to ask questions related to their specific situations--something they cannot do comfortably in local hotel-based group classes that may include competitors. Plus, on-site training ensures that every employee receives consistent information.

If your device is sold in several major markets, the MDSAP is a great way to streamline your QMS compliance activities. Contact us for more information or a proposal for intensive MDSAP awareness training conducted at your facility.

MDSAP training FAQs

Who should attend the training?
Typically, this training is attended by Management and Quality / Regulatory personnel, including internal auditors.

Do employees receive a certificate after the training is completed?
Yes, we will issue each attendee a signed certificate within one week after the training. The employee must attend the entire session to qualify for a certificate.

What is the daily training schedule?
Training generally runs for 8 hours each day and includes a one-hour break for lunch and two smaller breaks in the morning and afternoon. However, this can be changed to suit your specific business needs.