Post-Market Surveillance

Vigilance – You are obligated, as a manufacturer, to report certain events relating to your medical device to various regulatory bodies and authorities. This can get complicated with more marketing geographies. Adverse events are important to document, investigate, and effect change.

PSUR/PMSR – A new requirement of the EU MDR states that medical device manufacturers must provide post-market reports relating to their devices. Depending on the risk classification of the device, these reports can be fairly tedious. 

Complaint Handling/Trending – All geographies require medical device manufacturers to document customer complaints. Customer complaints contain some of the greatest feedback relating to your device. It is your obligation to document these as they come in, investigate them, and report them if necessary. Coding your complaints helps annual data analysis detect trends before they become big issues.

Medical Device Tracking – You made all these medical devices…now, where are they? God forbid your company must institute a total recall (removal), you need to have a way of tracking where these devices have been since they left your plant.

Corrections/Removals – Sometimes, your original design needs some modification. This isn’t necessarily a bad thing, but it can be wearying with the more devices you have. These recalls need to be managed and documented in order to be as effective as possible.

Operational Support

CAPA – CAPAs are part of the backbone of your manufacturing company. CAPAs and nonconformances on the whole play a huge role in monitoring and measuring your quality management system. Don’t let them scare you, and don’t let their importance be underestimated. The key here is to have a solid framework by which you can properly investigate, evaluate, and effect change because of the nonconformance.

Supplier Quality – Making sure your suppliers are continuing to operate to your required quality and specification is one way to ensure your products are continuing to be produced uniformly and safely. This requires annual supplier quality reviews, updating contracts, reviewing supplier corrective action requests and follow-ups, amongst other tasks.

Training – Training to quality management system processes, product use, and regulations and standards can help keep your company meeting quality standards. Proper training can prevent nonconformances and product quality issues down the road.

Data Entry – Entering data into a computer system or database can be time consuming and pulls away your specialists from doing things worthwhile. Hiring someone to dedicate their time to this and only this can save time and money along the way. 

Project and Program Management – Professional project and program managers can help get your project or program up and running efficiently and effectively. These professionals are experts in time management and risk mitigation. Don’t let confusion over authority and responsibility cause unnecessary delays.

Internal Consulting – Our med-sherpa consultants are here when and if you need us for any medical device related questions or work. We can be your silent partners or your most active employees—it’s up to you and your company’s needs..

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