While time to market is critical in any industry, medical device manufacturers especially want to get their devices approved and to market as fast as possible to begin making a profit. However, quality assurance is an essential part of the process, and medical device manufacturers cannot skip steps or cut corners if they want to meet compliance and federal and international standards. Ensuring medical device quality also is critical to keeping the bottom line in check and keeping investors, doctors, and patients happy so you stay in business.

There are a few strategies medical device manufacturers can implement to satisfy quality assurance and regulatory standards and remain in good standing with the public:

  1. Get your quality plan correct
  2. Establish electronic document control
  3. Invest in an integrated medical device quality assurance software system or service
  4. Perform a mock FDA audit

If you’re looking to find ways to improve your quality assurance and management practices, read on for more details on how to use each of these tactics to your advantage.

Get Your Quality Plan Correct

Ultimately, the key to medical device quality assurance is having a correct quality plan in place. When you deploy and execute a quality plan correctly, you close compliance gaps and solve problems. A solid quality plan sets a framework for your program. Quality plans also should establish quality expectations and metrics and outline your quality policies, procedures, practices, and guidelines. Use your quality plan like a checklist to verify that your process and project meet quality requirements. Keep in mind that quality plans also must be part of product development for them to be effective.

Begin by creating a site quality plan that describes exactly how your company’s quality policy accounts for creating quality procedures to meet local and federal regulations and quality system practices. Consider including sections like quality management overview and quality effectiveness reviews in your site quality plan. Be sure to include in your quality plan when design controls are initiated. It’s also best to be concise and direct with your plan and to include references when appropriate. It’s key to include information and references for carrying out tasks but to exclude excess information that could lead to gaps in compliance.

Establish Electronic Document Control

Documentation is the cornerstone of a compliant quality management system. Your documents and records should prove that your medical device company utilizes compliant document management practices throughout the design, development, and manufacturing processes. One of the first things your medical device company should do is determine how you will manage your documents and records in the present and into the future.

Begin by developing a document management strategy. Determine which documents and records you will generate throughout manufacturing the medical device. Know exactly which documented evidence you will need to prove you have followed your quality management system activities as you had planned. Don’t forget about supplier evaluation records, qualification records, and approved supplier lists. Device history records, complaints and customer feedback, corrective actions, nonconformances, and change orders are some of the other documents and records to consider.

Invest in an Integrated Medical Device Quality Assurance Software System or Service

With all the FDA and ISO regulations outlining government and industry standards, medical device manufacturers often spend more time documenting processes to meet standards than they do designing and improving their devices. That’s why so many medical device manufacturers are investing in integrated medical device quality assurance software systems and services. These systems and services streamline quality processes like corrective and preventative actions (CAPA), change control, audits, and training. Integrated medical device quality assurance software systems and services deliver the tools manufacturers need to achieve a streamlined process and manage one centralized system.

Perform a Mock FDA Audit

If you are not sure whether your concerns about your quality assurance practices are warranted, conduct a mock audit of your processes by a third party to get the answers you seek. The mock audit will help you determine whether you need to improve quality processing systems, your validation processes, etc. Sometimes, a poor mock audit is the best thing that can happen to a medical device manufacturer because you can make improvements before the FDA or state auditors come. You may find that you need to better audit your digital signature process or enhance employee training. If nothing else, the mock audit will prepare your staff for reacting to and responding to auditors. It also shows your employees that high-quality work is a must.

As the medical device industry faces increased spending on quality assurance and a greater emphasis on avoiding quality events, medical device manufacturers are focusing on quality and reliability at each step of the way through design, manufacturing, and marketing. To improve and streamline your quality assurance processes, spend time perfecting your quality plan, establish electronic document control, invest in an integrated medical device quality assurance software system or service, and perform a mock FDA audit.

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