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GENOTRIX

In-House Services

You can also contact us for stand alone services or features to increase and optimize your product development.

Product| Process - QMS Audit, Elaboration, Development

GENOTRIX can help you and develop your QMS System from the initial steps to the final certification. If you have already a QMS system implemented we can also setup a local audit for several purposes.

In the end, and no matter the approach, you’ll get a report for improvement or other relevant questions and issues we think you can adjust and optimize to get a more solid system.

Regulatory Expertise (CE Marking)

Ask for more information and procedures to apply for the CE Marking and start your entrance to the market.

Device Development Planning (Design & Engineering )

Our knowledge and experience will accelerate your medical device design and development and help you to get a fast manufacturing process and control of your medical device.

Device Commercialization

Contact us for questions and strategies to get your medical device ready to enter the market. We will guide you at each single step you need to fulfil to be compliant.

Clinical Evaluation Assessment

We can design and implement your clinical trial and evaluation and manage everything from the beginning.

Assembly, Packaging, Delivery

If your product need an operational and logistic approach we can also do it. Our facilities and localization are strategically prepared and placed with that option in mind.

Custom Services

If you're looking for a fully compliant service you can also count with GENOTRIX. Click here for more insights about our custom-made services.

Labelling

We understand the complexity when deciding which label would be the most suitable for your project.

Clean room environment

We also have a clean room at your disposal. We are able to assemble any medical device in controlled environment ensuring ensuring protection of medical device functionality and safety.

Steam Sterilization

GENOTRIX has a steam sterilization controlled service available. This process is nontoxic and widely used for several purposes and uses a steam where we can control the pressure, temperature and time that best suits your medical device.

GENOTRIX

Expertise

If you are looking for a partner to enter in the EU market or you’re looking for someone to take care of your regulatory compliance GENOTRIX is your best option.

EU Authorized Representative

- MD registrations.
- Advisory on labelling, advertising and communication.
- Responsible for Technical File or CE Declaration of Conformity.
- Assistance with the Incident and Field Safety Corrective Action reports.

Person Responsible for Regulatory Compliance (EU PRRC)

- Keep tracking, updating and controlling all the Technical documents and Declarations of Conformity keeping everything up to date.
- Supply chain QMS conformity
- Control and ensures all the PMS reporting responsibilities.

International Roadmaps

Design and preparation of all the regulatory compliance you need for a international markets. Our experienced team has a deep understanding and knowledge of the international markets regulatory systems.

Expertise MD | IVD At a glance -Summary.

- Product Specifications and Market Compliance
- Straightforward Communication with Regulatory entities and market clearance
- Safety, Performance and Product Communication
- Risks analysis and Post-Market Surveillance
- Quality Management System
- Market Strategy and Performance evaluation

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