F3

Regulatory Affairs

F3 offers comprehensive expert services for medical devices (MD) and in vitro diagnostic (IVD) medical devices that cover the entire product lifecycle, from establishing a quality management system (QMS) to post-market surveillance (PMS). Utilizing our expertise in your product development projects ensures that all regulatory requirements are taken into account from the very beginning. Our team will guide you through the CE marking process and help you prepare the required documentation. If your product is already on the market, you can outsource any post-market duties to us.

Our experts can help you in various tasks throughout the product lifecycle, whether you want to place your device on the market in the European Union or outside the EU. We are here for you if you want to CE mark your device in compliance with the Medical Device Regulation (EU) 2017/745 or the In Vitro Diagnostic Regulation (EU) 2017/746, or register your product in countries outside the EU, which in the USA may require expertise related to the FDA 21 CFR Part 820 and 510(k).

F3 Team has direct access to a wide range of specialist expertise in other fields – this allows us to provide comprehensive advice, for instance, for substance-based devices and combination devices.

Technical documentation for medical devices and ivds

F3 offers a wide range of services related to the technical documentation of medical devices and IVD medical devices. Whether you need to draw up technical documentation for a new device or bridge the gap between the existing documentation and regulatory requirements, or you have specific questions regarding the technical documentation, we are happy to help.
If you want to CE mark your medical device and place it on the market in the EU, the technical documentation must comply with the applicable requirements in the Medical Device Regulation (EU) 2017/745 (MDR) or the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR).
Other markets outside the EU have their own requirements for the device’s technical documentation. We can assist you in compiling and managing the technical documentation of your medical device or IVD medical device also outside the EU. To make sure your documentation will comply with the applicable requirements, we can perform a gap analysis between your existing technical documentation and requirements of the MDR/IVDR in the EU or other applicable requirements in the markets outside the EU.

We can also assist you in drawing up the technical documentation for your device, including the following:

device description and specifications

labelling

packaging and instructions for use

general safety and performance requirements checklist

risk management documentation

documentation related to product verification and validation

technical documentation on post-market surveillance (PMS).

You can ask us specific questions related to the technical documentation of medical devices and IVD medical devices, such as questions concerning the structure of the technical documentation or the requirements of a specific area of the technical documentation, such as risk management. If you need a review for your technical documentation, we can make sure it meets the regulatory requirements of the MDR/IVDR or the applicable legislations in the markets outside the EU.

Clinical and performance evaluations

Clinical evaluation or performance evaluation is an essential part of the conformity assessment of devices. Our experts can help you to meet these clinical evaluation and performance requirements. In the recent years, the bar has been rising for clinical data requirements both in the EU and outside the EU, and the question of whether there is enough clinical data available from equivalent products or if clinical investigations are needed is of critical importance.

We can provide the expertise and resources in:

Creating product-specific strategies to meet clinical data requirements

Writing clinical evaluation and performance evaluation plans and reports

Planning, performing and reporting systematic literature reviews

Writing post-market clinical follow-up (PMCF) and post-market performance follow-up (PMPF) plans and reports and assisting in PMCF/PMPF activities

Medical Device Regulation (EU) 2017/745 (MDR) MDD Clinical Evaluation Report

In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) IVD Performance Evaluation Study

Medical device clinical evaluation refers to the process where the manufacture validates whether the product meets the operational requirements or falls within the applicable scope through clinical literature, clinical data, and clinical trial. In the performance evaluation for an IVD medical device key aim is to demonstrate the performance (analytical performance and clinical performance) of the envisioned IVD medical device for the intended use as stated by the manufacturer. Our in-depth knowledge of medical devices ensures that your investigations and studies meet the recent requirements for clinical investigations and performance studies set forth in the standards.

Product registration

We offer professional medical device registration services globally and is currently committed to the registration approval certification of CE (MDR, IVDR, PPE, AIMDD), FDA (l510K), Japan, South Korea and other countries.

By utilising Effetre team’s extensive experience in your product development projects, you can be sure that all regulatory requirements are considered early on from the start. We can make sure that your product is compliant with the regulatory requirements in various markets, both in the EU and outside of the EU.

Our team is experienced in successful product registrations in cooperation with local representatives in several markets around the world.

Post-market surveillance and vigilance services for medical devices and ivds

Do you need help in creating a post-market surveillance (PMS) system that meets all applicable regulatory requirements? Our experts can support you in establishing and developing your post-market processes or if you need an extra pair of hands, you can outsource parts of your process to us.

Consultation on post market surveillance (PMS), post market clinical follow-up (PMCF) and post-market performance follow-up (PMPF)
Consultation on vigilance procedures
Coordination of post-market surveillance activities
Specific tasks related to PMS, PMCF and PMPF (such as systematic literature reviews and vigilance database searches)
Incident and field safety corrective action processing and reporting

Legal Support

Dispute Management: Representing clients in legal disputes relating to regulatory matters.

Border line regulatory: Representing clients in authority disputes relating to border line regulatory.

Contractual matters : draft and review contracts relating to the quality agreement & regulatory assessment related customer and supplier.