Post-Market Surveillance Flatrate
With the Post-Market Surveillance Flatrate, you can quickly and easily meet the post-market surveillance requirements for your medical device. Whether you have a single product or several different products, our PMS experts will adapt to your requirements.
And the best part? Our experts also take care of the procedure descriptions (SOPs) and PMS plans as well as all the necessary reports for the notified bodies. So you are perfectly positioned right from the start.
We have not reinvented the wheel. Just Post-Market Surveillance.
Subscribe to our Flatrate and introduce us to your product(s), including QM.
Setup: We work with you to create the SOP(s), all templates & PMS plans.
We collect, categorize and analyze the data according to the PMS plans.
We finalize our preliminary assessment with your risk management, including any actions.
You will receive regular reports for reporting to your Notified Body.
Benefits
Templates and PMS plans included
The setup includes everything you need for PMS according to your QM, including regulatory consulting.
Ongoing data review
We take the constant doing off your hands, collect the data and pre-evaluate it.
Efficient internal coordination (RM & PM)
We efficiently coordinate our preliminary assessment with your project & risk management – saving you time.
Fixed monthly rate
No more “takes longer” and “costs more”. You pay the same every month.
Certified quality
We are ISO 13485 certified, to ensure the best quality.
Flexible and scalable
Need PMS for fewer products? Or more? Neither is a problem.
Customizable to your needs
The right PMS has to match the right product. We make sure of that.
Â
Regular reporting
You are always up to date and have all the PMS reports you need to report to your Notified Body.
Our Post-Market Surveillance Flatrate
PMS Flatrate
No more “takes longer” and “costs more”. With our PMS flatrate, you are on the safe side. Do you have any questions? We are here for you!
starting at  1,695€ /M
(The monthly rate depends on several criteria such as product class, newness of the technology or complexity. We will be happy to advise you).
plus setup (one-time):
4,995€
Including:
- Creation of the PMS plan, including all templates and associated regulatory advice, to match the product and your QM system (setup)
- Regular research in external data sources (e.g. literature, reporting databases, social media, etc.) based on the PMS plan.
- Regular evaluation of internal data (e.g. complaints, production) according to PMS plan
- Regular incorporation of new pre-evaluated clinical data into the overall evaluation according to the PMS plan
- Regular consultations with your risk and project management according to the PMS plan
- Regular preparation of reports for the notified bodies according to the PMS plan
- Annual review and, if necessary, adjustment of the PMS plan
Frequently Asked Questions about the Post-Market Surveillance Flatrate
How do I know what I have to pay each month?
The complexity of post-market surveillance depends on many factors (e.g. the risk class or the novelty of the technology). We want to take the complexity out of it from the start. That is why we have prepared a short list of questions that will help us find the right package for you. Contact us and we will find the right package. Of course, we will also answer any other questions you may have.
Is the setup fee due for each product?
Yes, it is. We have to go through the same normative rules for each individual product and determine whether they need to be applied or not. So the resulting PMS plan is individual for each product.
Can I use the reports generated by Custom Medical for my Notified Body?
Yes, you can. That’s what the reports are for.
Does Custom Medical report directly to the Notified Body?
No, not as part of the PMS plans. However, as part of the plans, we provide you with everything you need to successfully report for Post-Market Surveillance. If you require additional support, we can arrange this on an individual basis.
How is the Post-Market Surveillance Flatrate billed?
After the order is placed, a one-time setup is performed for each product. This includes the creation of templates, SOPs and PMS plans. The setup is charged once per product.
On completion of the setup, the monthly invoicing for your booked package begins and we start regular post-market surveillance according to the agreed PMS plans.
If you add another product at a later date, the process starts again. First the one-time setup for the added product, then the monthly billing.
What happens if I cancel the Post-Market Surveillance Flatrate?
If you no longer need us, you can of course cancel at any time. In the event of cancellation, we will continue to work on active tasks as normal until the end of the cancellation period. If reports are due to the Notified Body during this period according to the PMS plans, you will of course receive them. After the cancellation period has ended, we will cease all work and delete any remaining data and reports.
What happens if I need PMS for more/less products?
If your needs change, we are as flexible as possible. If you need our support for additional products, we can usually start the setup within a week and complete it with you within another week.
If you want to have fewer products monitored, you can cancel each product individually. This allows you to remain flexible and respond quickly.Yes, we are a full-service usability engineering provider for medical device and IVD manufacturers. Our services range from initial product strategy, user interface design, product design and front-end development to international usability evaluations.
Get in touch and find out more about the Post-Market Surveillance Flatrate!
