Enerxen

Enerxen
Enerxen

PMS

Post Market Surveillance

Continuously monitor the performance and safety of your product

Ensuring that your device works safely and effectively from the start is of paramount concern, but it’s also critical that it performs well in the long term. Enerxen will use all our resources to carefully monitor and measure performance over time. Should we be alerted to any reduction in performance and/or malfunction, corrective actions will be immediately taken.  

  • Analysis of data and creation of PMSP: Post market surveillance Plans, PSUR: Periodic Safety Update Report, PMSR: Post market surveillance reports, CER: Clinical Evaluation Reports and PMCF: Post market Clinical Follow-up
  • PMSP/PSUR/PMSR and CER orientation training courses and practical classroom instruction on preparation of PMSP/PSUR/PMSR and CER

Help with PMCF issues

Are you having difficulty figuring out what the latest post-market regulations are? Enerxen Consulting has a full understanding of all the requirements and can help ensure that your devices remain safe and effective. This will not only give you peace of mind, it will help you in growing your business. Our team is completely proficient on all the latest requirements and industry trends. We will not hesitate to use our connections to find out what needs to be done.

Need post-market surveillance?

Analyze data to create effective PMS, PMCF, PMPF plans and PMS, CER, risk integration reports, to include operational processes and team alignment

Evaluate risks

Analyze and assess what problems could occur with your medical device. Getting prepared for the worst is never any fun, but you have no choice with so much at stake. Enerxen Consulting has the expertise to thoroughly handle post-market surveillance in all its aspects and can work with you to quickly and efficiently put a viable plan in place.

Overcome issues without losing momentum

Monitoring safety risk, complaints and CAPA are three critical aspects that you must stay on top if you expect to succeed as a medical device company. If one of your devices is recalled, you can rely on Enerxen Consulting to successfully get you through it. We’ve been down this road many times before and will work closely with you to ensure that every last detail is resolved.