SOLUTIONS FOR

YOUR PROJECTS

ISO 13485:2016 CERTIFIED
MEDICAL DEVICE CONSULTING SERVICE

Who We Are 

We Are a Team of Engineers and Subject Matter Experts with a long experience in the Medical Device field, this allow us to quickly find the right approach for the project, optimizing development basing on regulatory field, applicable international standards and previous experience with the biggest market leader companies.

Customized Solution:

We support our clients on a specific service or on a whole project development. We tailor our solution on client needs.

From Concept Design to the Final device

Medical Device Design and Development


We can support and guide trought all the develoment process. Defining and addressing the User Needs, matching Technical possibilities to Business needs to find best solutions and finally develop a successful product!

We provide support to our clients in getting trought all the product development stages.

From ideation to final market introduction.


We are ISO 13485 certified for Medical Device Design, Development and all related activities.

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MDR & Regulatory Support

MDR 2017/745 CONSULTING SERVICE

With our team of SMEs and Regulatory experts we provide support to companies in different fields and with different kind of products going through the changes introduced by new MDR.

We will start with a Gap Analysis to assess your current level of compliance and highlight gaps.


Then we will define a proper MDR Transition plan to help you navigate trought the change and reach safe the harbour of MDR compliance.



THE NEW REGULATIONS WILL ENSURE:

• a consistently high level of health and safety protection
for EU citizens using these products
• the free and fair trade of the products throughout the EU
• that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.

We can help you out and support on hot MDR topics such as: 

        • CLASSIFICATION AND CONFORMITY ROUTE
        • NOTIFIED BODY SELECTION
        • UDI / EUDAMED
        • TECHNICAL FILE
        • CLINICAL EVALUATION
        • PMS PROCESS
        • QMS GAP ANALYSIS
        • SOFTWARE AS MEDICAL DEVICE
        • 3D PRINTED MEDICAL DEVICE
        • COMBINATION PRODUCTS

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        Quality & Validation

        QMS and Process Validation Support

        We support establishment of QMS Quality Management Systems for the Medical Device and Pharma sector in compliance to ISO 13485:2016 and cGMP standard.
         

        We provide our experience and support in order to:

        It is necessary to show that there is full control over all life cycle of a product starting from the ideation, the definition of constraints and specifications, the choice of the design, the production process.


        Process Validation is key for reliable manufacturing


        We can support in

        • Performing IQ/OQ/PQ process validation
        • Drafting GAMP5 documentation eg. URS, FDS, HDS, SDS


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