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.

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.


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

        Moreover we will be presents at this event
        www.innovabiomed.it


        We provide also:

        • EU AUTHORIZED representative
        • PRRC;
        • UK RESP PERSON

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        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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        Usability & Human Factor Engineering Consulting

        Our Service


        Full regulatory compliance to EU and USA requirements- ISO 62366, FDA Guideline

        • Risk assessment of human factors
        • Wide variety of usability assessment tools

        From standard review to user testing, from heuristic analysis to time-and-motion studied

        • Design and re-design (device & information for use)
        • Usability validation (summative & formative)

        Field of Application of HFE expertise and support:

        • Medical Devices in All Healthcare Domains
        • Medical Device Accessories
        • Websites and Mobile Applications
        • Health Information Technology
        • Documentation and Training
        • Anthropometrics and Accessibility
        • Signage and Labeling
        • Instructions for Use


        Reach out to us now and we will be able to support you!

        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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        SMART TOOLS FOR COMPLIANCE

        We provide top-level consultancy and also the digital tools to streamline compliance and save time and costs

        UDI EUDAMED TOOL

        Web App

        • Dedicated back-end
        • Revision management
        • Fill all UDI-DI field
        • Fill all Basic-UDI field
        • Dashboard for easy monitor UDI status
        • Easy search
        • Duplicate function
        • Export XML for EUDAMED (optional)
        • Blockchain Audit Trail (optional)


        E-IFU

        Web App

        • Dedicated back-end
        • Revision management
        • QR scan and download
        • Language management
        • Local language recognition
        • Blockchain Audit Trail (optional)


        E-QMS

        Modules available:

        • Design Control
        • Document Control
        • Equipment Management
        • Electronic Signatures
        • Product Management
        • Post-Market Surveillance
        • Risk Management
        • Supplier Management