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Risk Analysis for Medtech

Order and clarity in the documentation throughout the entire Medtech project

Secure your product on the market with an approved risk analysis!

A basic requirement to get to the market launch and start selling your medical device is a correctly performed risk analysis. Without this, you simply cannot sell medical equipment of any kind.

All too many start with the documentation when the project has already taken off and before you know it, the workload to catch up has become overwhelming. No worries! Our service, "Risk analysis OnDemand", offers tailormade solutions to structure your risk documentation efficiently and securely.

Our experts act as your quality department and together with you we ensure that the documentation meets all the necessary requirements. You can continue to develop and plan for the market launch.

Book a meeting with us today to take the next step towards your ready-to-sell Medtech product!

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It's easy to get help!

However, doing the risk analysis work according to all the regulatory requirements can be complicated and time-consuming. Are you stuck or running into difficulties? Or maybe you just don't have time to do everything that needs to be done and documented?

Then we have a really good suggestion! You are only 5 steps away from an approved risk analysis.

May 26, 2024 is a decisive date for all companies that manufacture and/or sell medical devices. 

According to the MDR Directive, an ongoing application for assessment must be initiated before this date in order to continue selling products within the EU. Without this, it will be illegal to market the products within the EU. 

For those products that require a notified body (including those previously classified as Class I, such as software), and where an application for assessment has not been initiated, the right to sell within the EU ceases. The Medtech products lose their previous status and cannot be sold again until an MDR assessment has been completed. Currently this takes approximately 15 months, but the waiting period can be extended.

Observe

Common questions and answers

How long does a risk analysis take?

It depends on where you stand with the preparatory work. The more you have worked on your documentation, the less time it will take to complete. This is something we examine together in the first meeting.

Who will do the risk analysis?

Together Tech's team leads the work and has expertise in both the process and the regulatory requirements. A risk analysis also involves all departments in your company, as your expertise on the product is crucial for a reliable result.

How do I know that Together Tech knows medical device risk analysis?

With many years of experience in medical technology and documented good results, you can trust us. Our cases include some examples of how we have helped others in the Medtech sector.

How much does it cost to carry out a risk analysis?

In order to make a cost estimate, we need to know more about your current situation. Book a meeting or send an email and we will set up a time to discuss your needs and then we will provide a quote.

Why should I hire Together Tech for my risk analysis?

In addition to the necessary theoretical knowledge, we also have over 30 years of practical experience in the entire medical technology product development process, both in-house and together with customers in their teams. We can overview all steps in the process and choose a level that is right for your product and your company. We assign a competent team that focuses on the risk analysis work and gets it done on time.

Claes Jonsson
Claes Jonsson
Manager Medical Device
Leonardo Milizia
Leonardo Milizia
Manager Medical Device
Sofia Nilsson
Sofia Nilsson
Manager Medical Device
bwda-breas
Case
Breas Medical is a global medtech company with over 30 years of expertise in ventilation, airway...
brain_medtech
Case
Developing stable and reliable medical software requires a great focus on quality, and to know if...
xpac
Case
Today, patients with respiratory problems are treated for less time in hospital because there are...

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