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Regulatory Affairs
Key2Compliance offers a wide range of services within the area of Medical Device, IVD and Regulatory Affairs (RA). Our team of specialists can support and guide you through the entire regulatory process, from idea to market, in exactly the way you need, fully adapted to your organisation.
Key2Compliance helps you to:
- Fill the role as PRRC, Person Responsible for Regulatory Compliance
- Perform product qualification and classification against applicable regulations
- Set up a Regulatory Strategy
- Guide you with regulatory support through a Product Development project
- Make GAP analyses of your technical files and documentation
- Make your technical documentation compliant by developing, upgrading or finalizing documents
- Plan and implement all different phases in the product life cycle, such as feasibility studies, development, post market, etc.
- Manage your risks and usability – all to have compliant Risk Management file
- Identify and develop necessary procedures for design, development and manufacturing
- Create instructions and guiding documents
- Take your product to the market
- CE marking
- FDA submissions, 510k, PMA and De Novo
- Register your Medical device/IVD products worldwide
- Increase knowledge of the regulations in the EU, USA and other parts of the world
- Support you when you need a second opinion
We solve your regulatory needs, in the way that suits you best
The regulatory landscape in the medical device industry has been constantly evolving and changing in recent decades. In the future, there will be new regulations that place even higher demands on medical devices. As the regulations differ between different markets, it is important to be active and stay up to date at all times. As consultants and specialists, this is something that we at Key2Compliance can help you with.
Our specialists have extensive experience of helping and supporting medical device companies with every regulatory issue. We have knowledge of the regulations and quality requirements within the EU, the USA and many other countries.
Key2Compliance are able to assist you, no matter if you are a small company, a startup; or if you already are a well-established company. With our specialist knowledge in several areas, we can assist you in a flexible and customer-oriented manner throughout the whole product life cycle, from idea to market, as well as to stay on top with maintaining your regulatory work.
Our specialist at Key2Compliance can help you with projects, targeted actions, continuous work needed in your company. Many times, you might just be in need of a second opinion. If needed, we would be happy to assist you with supporting you as a RA Manager within your organisation to lead your regulatory work. We can help you with both minor and major assignments completely based on your needs.
We can carry out the work on site with you or you can also let our in-house consultants run the projects and assist you from our offices.
PRRC - a Person Responsible for Regulatory Compliance
A PRRC, a Person Responsible for Regulatory Compliance shall be permanently and continuously at their disposal and must also be a person possessing the requisite expertise in the field of medical devices.
This new role becomes mandatory for all manufacturers and EU authorised representatives from the respective EU Regulation, i.e., 26 May 2021 for the MDR and 26 May 2022 for the IVDR, as outlined in Article 15 of the MDR and IVDR.
As there might be difficulties for companies defined as micro; or small, to have one or more appointed person(s) for this, this role may be outsourced to an external expert. At Key2Compliance® you will find highly qualified specialists to take on this particular role. To this you can also be assured that our specialists are certified within this particular area.
The PRRC shall see to that your company are able to fulfil the requirements of the MDR/IVDR, and the areas to cover this is to keep the technical documentation and the EU declaration of conformity up to date; Vigilance Handling and keeping the reporting timeframes, Post-Market-Surveillance, and also see to that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is being released.
Free webinars
The IVDR challenges – do you have everything under control?
Recording from Dec 14th, 2022 with Susanne El Makdisi, Susanne Grimsby and Emily Malmberg.
Electrical safety according to IEC 60601 →
Recording from webinar Jun. 17th. 2022 with Marcus Mellin and Gustav Sundström
Performance Evaluation for an In vitro Diagnostic Medical Devices
– How to reach IVDR Requirements →
Recording from Mar. 24th. 2021 with Johanna Fugelstad and Katalin Holenyi:
Please do not hesitate to contact us if you want our support.
Improve your risk management procedures
ISO 14971:2019/A11:2021 is now harmonized with EU Medical Device Regulation (MDR) 2017/745 and EU In Vitro Medical Device Regulation (IVDR) 2017/746 IVDR.
Understand its importance and how it affects your business.
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