Is the thought of achieving and maintaining regulatory compliance stressing you out?

It's a good thing that our friends in the pharmaceutical industry excel at producing quality products because medical device manufacturers often need anxiety medication when they think about regulatory compliance.

Due to some unfortunately high-profile cases, the FDA is under more scrutiny than ever to make sure that medical devices are as safe as possible. In fact, many lawyers make a living soliciting consumers to join class-action lawsuits specifically against manufacturers that didn't prioritize quality in their companies.

The good thing is that you can learn from the mistakes of other manufacturers. You can avoid the pitfalls that commonly cause irrevocable damage to your customers and leave you vulnerable to regulatory compliance problems.

When you put quality first, you establish the foundation that will save your company money, bypass headaches, and avoid the reputational damage that comes with medical device regulatory compliance issues.

5 Medical Device Regulatory Compliance Problems to Watch Out For

Your peers have laid the groundwork before you — both good and bad. Some have delivered amazing products that have changed lives, and others have put profits before quality and damaged their companies.

The good news for you is that you don't have to follow their bad examples. Learn from these five common medical device regulatory compliance problems and build a stronger organization that will dominate your market.

1. CAPA Issues

CAPA violations accounted for nearly one-third of all FDA 483 Observation Letters issued in 2018.

483 Letters are issued to document potential violations of the FDA's requirements. They are a matter of public record and can harm your reputation with your customers. The FDA can also escalate to warning letters, and then further action will be taken if the violations are not addressed.

Violations typically occur because organizations:

  • Are not following CAPA processes
  • Don't comply with cGMP.
  • Don't have a defined CAPA process or Enterprise Quality Management (eQMS) capabilities.

The Solution:

CAPA procedures and systems are not optional. Ineffective investigations can threaten your quality, compliance, and ability to lead your market.

  • Make CAPA a foundational core of your business.
  • Don't let your team rush through CAPA procedures.
  • Be sure to perform the most thorough root cause investigation possible without jumping to conclusions. New call-to-action

2. Inadequate Purchasing Controls

Your supply chain provides the raw materials and inputs that you need to manufacture your devices. It's no surprise that your products will not meet standards if you fail to get high-quality materials.

Despite the obvious connection between materials and end products, last year, one out of six medical device manufacturers that received an FDA 483 citation were non-compliant with 21 CFR 820.50, Purchasing Controls.

Supplier quality is becoming more of a focus for the FDA as more and more manufacturers are outsourcing to reduce cost and increase output.

The Solution:

  • Take the time to properly identify risks in your supply chain, including rapid growth, facility changes, supplier changes, IT systems, and supply chain size.
  • Be consistent in how you evaluate your suppliers. This doesn't mean that you should evaluate them all the same way, but you should use consistent and documented processes for conducting evaluations.
  • Avoid choosing the cheapest supplier. You should consider the cost of your supplies, but cost should not be the predominant deciding factor.
  • Create airtight supplier quality agreements that carefully and meticulously outline your quality requirements for your partnership.
  • Invest in an eQMS that can help you manage your approved supplier list (ASL) and track your interactions with suppliers.

Related Reading: The 4 Worst Supplier Quality Management Procedure Problems for Life Sciences Organizations

3. Errors in Complaint Procedures

In 2017, Complaint Procedures were the second most common reason for FDA 21 CFR 820 warnings being issued.

Complaints include any written, electronic, or oral communication from a customer that alleges any fault with your device. Fault can include any deficiencies in the identity, durability, quality, safety, reliability, performance, or effectiveness of your device.

The Solution:

  • Establish procedures for how you will receive, review, and evaluate any complaints received.
  • Designate a formal unit responsible for handling complaints.
  • Document all complaints and all activity on those complaints in your eQMS.

4. Process Validation Hangups

Conducting tests on every device or drug that you produce isn't practical (or possible). That's why organizations and the FDA evaluate your quality management systems instead. Validating your process thoroughly should result in you being able to produce consistent and high-quality outputs that meet standards every single time.

The US FDA defines process validation as a “means [to] establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.”

The FDA is looking to determine that your processes have been "validated with a high degree of assurance and approved according to established procedures." They also want to ensure that you "establish and maintain procedures for monitoring and control of process parameters for validated procedures."

The Solution:

  • Your initial process validation won't be simple, and it won't be cheap — but don't rush through or skip steps. The money and time you invest now will save you in the long run.
  • Take time to evaluate all processes and determine which ones require validation.
  • Examine all variables in your supply and manufacturing chain.
  • Use sound statistics for sampling that includes an adequate sample size and repeated tests with consistent results.
  • Test your devices for worst-case conditions.
  • Investigate any failures and identify the true root cause before taking corrective actions.

Related Reading: Solving the Four Most-Common Quality Management Issues

5. Faulty Document Control

Document control is the overall process for managing your documents — from initial creation through to maintenance, access, and eventually archival. ISO 9001 contains specific requirements for the control of your documents, but it also contains significant flexibility.

ISO 9001 doesn't tell you which documents require controls, how many approvals are needed, or how your documents should be formatted or labeled.

However, if you fail to comply with the requirements of ISO 9001, you won't pass an audit.

The Solution:

  • Documents can be stored in a wide variety of file types, including paper or digital, but they must be able to be easily identified. Consider using metadata, titles, or tags that make it easy to find the documents you need.
  • Ensure that you identify versions on your documents so that your team and auditors can be confident they are looking at the most up-to-date version.
  • Your approval trail should be clearly documented, and only people with authority should be doing the approvals.
  • Access to documents should be limited to only the people that need to have access to them to protect data integrity.
  • Use an eQMS to control documents, including workflow management, approval tracking, version controls, and collaborative editing.

A Great eQMS Can Solve Many Common Medical Device Regulatory Compliance Problems

It's true that just having the right software isn't going to solve all your problems — but it will greatly reduce them.

Paper-based systems may be comfortable, but with today's strict regulations and stiff penalties for even the smallest of failures, you can't stay stuck in the old ways of doing things any longer.

Cloud-based eQMS platforms give you the audit-ready "paper" trail that you need to improve quality across your entire production process and prove to auditors that you're following regulations.

The Benefits:

  • Real-time collaboration on documents without having to shuffle and email copies all around the office.
  • Version management so that you know the latest version is being distributed.
  • Approval workflows that enable you to get the right people to sign off at the right stages of the documents.
  • Training management that allows you to assign and track training — including both in-platform and external training.
  • Access controls to ensure that only the right people can access the documents.

And that's just scratching the surface. At Qualio, our mission is to help you build a
culture of quality that enables you to change the world with life-altering devices. We want to help you quickly and efficiently develop high-quality products that serve your customers and lead your market.

Schedule a demo of our software and let's talk about your unique needs and challenges and see how we can help you succeed.

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Published by Robert Fenton November 19, 2019
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