26. 09.2018

5 tips for post-market medical device compliance

Post-market surveillance is an important process for medical device developers, with regulatory bodies expecting you to follow through and have effective procedures.

In fact, post-market surveillance is a compliance issue that many companies get caught up with in audits or inspections. So how comfortable is your medtech company with the process?

The usual story is that the company doesn’t have a procedure in place, or, if they do, it’s ineffective with a lack of follow-up or important issues being missed. Any situation like this can land you in hot water with work to do to get back in compliance.

Your work is not done once your device has hit the market, so what does it take to be compliant in a post-market environment?

1. Keep up with regulatory changes

Who can honestly raise their hand and say they’re intimately acquainted with every regulatory change that has come out and affects their company within the last few years?

Most people will know the basics of the big changes, but the truth is, there are small changes happening frequently and it’s easy for those things to slip through the cracks.

Information is your friend in a post-market surveillance environment and in the medical device world as a whole. It’s important to take proactive steps to stay informed and understand how your company needs to be prepared for any key changes.

Some suggestions to help facilitate a proactive approach include:

  • Attend conferences, trade shows, meetups, trade association meetings and training sessions. Engage with decision makers, regulatory advisors and people “in the know” at these meetings to get the low-down on any developments.
  • Monitor industry websites and forums.
  • Talk to any regulatory contacts you may have, or people who sit on advisory committees.
  • Subscribe to industry publications (and take the time to read them). There are often nuggets of information to be found that can give you an idea of anything you should be preparing for.

2. Monitor feedback.

Staying abreast of feedback is another challenge for medical device companies in a post-market phase. The issue is that feedback can be coming at you from multiple channels. For example, customers might file a complaint, but use different methods to do so – email, feedback forms, social media, a phone call…

Feedback might also come from clinicians or caregivers who help the end users. It might come from service technicians, study groups or reports on non-compliances. It might even come from a resulting CAPA investigation and lead to changes having to be made.

The point is you’ve got to have a system in place to handle the various channels of feedback and ensure that nothing slips through unchecked. Companies have found themselves in trouble where there is no sign of feedback having been followed up, for example.

3. Put systems in place.

What systems do you in place to ensure that feedback is scrutinized appropriately and that everything is captured? What about other critical post-market activities – internal audits, CAPA management, updating your risk management file, change management and management of any non-conformances?

Companies who end up with issues often have a fragmented approach, with customer service taking and filing complaints (perhaps in their own spreadsheet), someone else looking after internal audits or CAPA, and no one updating the risk management file until there’s a pre-audit scramble. This can often lead to issues identified at audit that could have been prevented.

On the other hand, a system that centralizes all of those things into one easily accessible spot (such as as Greenlight guru’s post-market QMS Software) can be a great way to stay on top of compliance. Generate reports, manage feedback and generally be prepared for any audit or inspection.

4. Establish follow-up studies where needed

Post-market surveillance studies (FDA) or post-market clinical follow-up studies (Europe) may be required, particularly among Class II or Class III devices. The purpose of these is to monitor and assess any residual risk that may exist with the device. It’s often the case that data is limited during pre-market studies due to factors such as the length of the study or the number of participants.

It can also be the case that studies are required due to significant changes to a device or its usage, new information that has come out or post-market surveillance data. Companies wanting European CE marking will need to have evidence of a post-market clinical follow-up (PMCF) study protocol or a justification for why a post-market clinical follow-up (PMCF) study is not required.

5. Keep your team up-to-date.

Your team plays a key role in how well you are able to handle post-market surveillance and any issues that may come up. They will need to be kept updated of any changes to policy, procedure or legislation and be supported through those changes.

An important task is to keep team members trained on investigative techniques, reporting and documentation procedures so that you stay ahead of the game. Include training on topics like spotting trends proactively monitoring devices.

Know the risks…

What happens if you fail to keep up with the steps outlined above and are found to be non-compliant during an inspection or audit? Well, the consequences can vary depending on the gravity of the offense, ranging from getting an FDA Form 483 observation all the way to the worst-case scenario which could ultimately mean jail time for executives who are involved with the non-compliance.

There’s also the risk of being handed down very large fines, having special compliance contracts imposed, seizure of products or effectively having operations shut down.

… and the benefits

It’s important to remember that post-market compliance isn’t some checkbox activity to be marked off and filed under “we did this to be compliant,” it actually provides some valuable benefits to your company and your customers.

For example, a good surveillance program allows you to quickly identify improvements that need to be made. Post-market surveillance provides you with an opportunity to be proactive, to take steps that result in valuable learning for your company. This proactiveness can, in turn, help to reduce your incidents of customer complaints, reduce safety incidents and foster engagement with customers.

Final thoughts

Post-market surveillance is a critical requirement of medical device companies that have devices on the market. It’s easy to breathe a sigh of relief when your device hits the market and be tempted to just “cruise”, but stricter regulation on post-market activities means that you really can’t afford to do so.

Source: Jon Speer
Medical Design & Outsourcing