SOLUTIONS FOR

YOUR PROJECTS

ISO 13485:2016 CERTIFIED
MEDICAL DEVICE CONSULTING SERVICE

PRODUCT

DEVELOPMENT 

MDR &

REGULATORY SUPPORT

Quality &

Validation

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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It ‘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.


It ‘important to confirm that in all these phases a repeatable method  has been used and demonstrate through records, documentation, procedures.


The choice of the validation procedure, the tests for the validation and related acceptance criteria must be defined based on reference standards and optimized according to the characteristics of the product or process that you want to validate.


We support the validation and the establishment of quality systems with particular reference to the medical device sector, with reference to ISO and GMP standards.

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

        We work for our client in order to get their product on the market efficiently and effectivly.

        We provide a full range of regulatory support service, with particular focus to:

        From ideation to final market introduction.


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

        It ‘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.


        It ‘important to confirm that in all these phases a repeatable method  has been used and demonstrate through records, documentation, procedures.


        The choice of the validation procedure, the tests for the validation and related acceptance criteria must be defined based on reference standards and optimized according to the characteristics of the product or process that you want to validate.


        We support the validation and the establishment of quality systems with particular reference to the medical device sector, with reference to ISO and GMP standards.

        TS QUALITY & ENGINEERING

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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


        Validate means


        “Providing an evidence documented by ensuring, with a high degree of safety, that a specific process (or subprocess) is able to make in a repeatable way a product that meets the specifications recorded and the quality standards predetermined”



        We perform validation of following processes

        • Injection Molding
        • Pharmaceutical Packaging
        • 3D Printing
        • CNC Milling
        • Clean rooms
        • Sterilization processes
        • Cleaning Processes
        • Heating treatments
        • Coating Treatments



        WE WILL HELP YOU CREATE A SUCCESSFUL PRODUCT


        We have huge experience in medical device design & development with particular focus to following fields:


        Orthopaedics


        Traumatology


        Neurosurgery

        Urinoginecology


        Cardiovascular

        Surgical Instruments



        6 STEPS FOR THE EU MDR GAP ANALYSIS



        1. CLASSIFICATION (CHAPTER V)

        • Check new classification rules (MDR Classes I, IIa, IIb and III) (Art. 51, Annex VIII) (eg. Surg mesh, software,etc…)
        • Check the new definition of MDR, particularly with respect to its expanded scope. This also applies to products covered in (Art. 1, 2, Annex XVI) (eg. Cleaning device, Contact lens, liposuction, skin treatment…)
        • Special Device (Art. 21) (investigation dev., etc..)


        2. CONFORMITY ASSESSMENT (CHAPTER V)

        • Confirm conformity assessment routes for existing and future products (Art. 52, Annex IX, X, XI) (eg. Class Ir..)

        3. CHECK NOTIFIED BODY STATUS


        4. REVIEW QMS AND TECHFILE


        QMS

        • Review and upgrade quality management system (QMS) (eg. Art. 10 (9))
        • Assess impact on products, internal resources, organisation and budget, ex. Person responsible for regulatory compliance (Art. 15)

        TECH FILE

        • Review the changes needed to existing technical documentation (Annex II)
        • Tech file conservation period (min. 10 yr after last device placed on the market Art.10 (8))


        5. PERFORM PMS (Chapter VII) and CLINICAL EVALUATION AND INVESTIGATION (Chapter VI) GAP ASSESSMENT


        6. EVALUATE NEW UDI AND TRACEABILITY REQUIREMENTS


        EUDAMED/UDI AND TRACEABILITY

        • Ensure the respect of traceability obligations UDI/EUDAMED (Chapter III)
        • Information to be provided upon registration (Annex VI)

        LABELLING

        • Review product labelling (Annex I ,Chapter III))
        • Implant card and information to be supplied to the patient with an implanted device (Art. 18)

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