5 Keys to Helping Your Device Company Gain MDSAP Certification

EDITOR’S NOTE: This is Part 3 of a trio of articles focusing on the Medical Device Single Audit Program (MDSAP). Read Part 1 here and Part 2 here.

Medical Device Single Audit Program (MDSAP) certification serves as a guarantee of the quality of a company's products and gives medical device manufacturers a competitive advantage by opening up large international markets.

Even if your company isn't currently selling products in the countries covered by the MDSAP (Australia, Brazil, Canada, Japan, and the U.S.), it's likely that you will in the future. Here are five key things you should start looking at now to assist you in making sure your device passes an MDSAP audit.

1. Transparency

Any medical device manufacturer looking certify its device with an MDSAP audit will need to show exceptional levels of transparency in its operations, from design and development through to manufacturing.

2. Access to information

The manufacturer’s quality management system (QMS) needs to provide auditors with quick and in-depth access to information. The data needs to be classed and organized in a way that makes it easy for auditors to access and that meets their requirements.

3. Knowledgeable staff

As part of the audit, auditors will need to interact with your company's own experts. They should be prepared to provide prompt and clear answers to the audit body’s (AB) questions. Be sure to pay especially close attention to the following:

• Make sure you allocate appropriate resources to the inspections.
• Involve heads of department as well as experts from design, supply management, production, complaint management and other areas. Audit preparation isn't just the job of the quality department. The work needs to be shared among all staff.

4. Companywide communication

If the MDSAP audit covers multiple sites within your organization:

• Make sure that any key lessons gleaned are passed on to other sites.
• Put processes in place to record the information requested by auditors, the questions they ask, and the materials you'll need to answer them.
• Send this information to the rest of your sites so that they can also prepare for the audit process.

5. Continuous improvement

Focusing on quality neither begins nor ends with the MDASP audit. During the audit process, other regulators will be looking for evidence that your company is committed to improving quality on an ongoing basis. When you're preparing for an MDSAP audit, you should look for ways to show auditors that you're going above and beyond the requirements. Demonstrate to them that you've integrated quality, continuous improvement and operational excellence into everything the company does.

Does your company have a strategy for regulations and quality management?

However big or small your company is, you should always make an efficient quality management system (QMS) one of your priorities. Keep in mind that you can make conformity with MDSAP requirements smoother by automating business processes. An electronic QMS can significantly aid your company’s ability to improve your processes, gain greater efficiencies and help you move toward excellence in quality

You should look into which QMS solution works best for you, and offers key features such as:

• Traceability of audit documents;
• Easily accessible documentary evidence and an efficient and structured way to share and work on documents with other staff;
• Quick access to data during inspections and audits.

Do you need guidance in meeting regulatory requirements? Don't hesitate to get in touch with us at www.apsalys.com.