Your Medical Device CRO
Devicia is your full-service Medical Device CRO, supporting you throughout the life cycle of your medical device. Our advice is always founded on our vast experience and our participation in technical committees – with us, you get the inside perspective.
- Unmatched Medical Device Expertise
- Offices in Sweden and the US
- Market focused – public and private clients
Medical Device Regulation, 26-May-2021
Make sure your device complies to the new EU Medical Device Regulation, MDR 2017/745. The deadline for the application is set to 26th of May 2021. Let us help you – you will have a smooth transition to the new regulation.
SERVICES
Full-service solutions for medical devices - examples of our services are listed below:
Regulatory Affairs
Let us navigate you through the regulatory landscape throughout the life cycle of your medical device. With offices in the EU as well as the US, and vast experience of both regulations we can provide you with a global perspective and hands on advice. Whether you need support identifying a suitable notified body, entering a new market, or making the transition from the medical device directive to the new EU regulation, we are here to support you.
Clinical Investigation
We have extensive experience with all types of clinical investigations and can support you with clinical investigations regardless of product, clinical developmental stage and type of design. We support you with clinical investigations before as well as after CE-mark (PMCF) and can conduct investigations throughout the EU and the US.
Medical Writing
Our medical writing team have extensive experience performing Clinical Evaluation Reports (CER) for all kinds of medical devices. We can support you finding the best way to prepare your CER in compliance with applicable regulations and guidelines. In addition, we can assist you with an efficient process to keep them up to date.
Professional Training
We customize lectures, training programs, and workshops covering a variety of topics and tailor them specific for your products and needs. In addition, we perform lectures and trainings for manufacturers, universities and notified bodies.
BioComp
Within Biocompatibility and Toxicology, we can support you in every step from selecting the right biomaterial, planning and executing a Biological Evaluation and by setting up Toxicology and Risk assessment strategies. We guide you through the increased requirements and help you fullfil all applicable regulations.
Economic operators perspectives
Throughout your supply chain, the MDR has brought new requirements for Manufacturers, Authorized representatives, Importers and Distributors, together called Economic Operators. Partner with us to make sure you are up to date and compliant with the new regulations - or if you want us to act as an economic operator for you.
WHAT ARE YOUR NEEDS?
With our full-service solutions, we support you in every step – from market access to post-market surveillance and follow-up.
Irrespective of type of medical device, we support you. Examples of products supported by our services:
– Medical Device
– In Vitro Diagnostics
– Combination Products
– Medical Device Software
5 REASONS TO WORK WITH DEVICIA
01
Medical Device Exclusivity
Our medical device expertise contributes to make safe products available for patients and users all over the world. Regardless of product, we are dedicated to assist you any part of the way.
02
Inside perspective
As members of the technical committees and nominated as experts in international working groups writing medical device standards, we can provide you with an insight perspective.
03
Full service CRO
We have extensive medical device experience within Quality, Regulatory and Clinical Affairs. We are dedicated to provide you with a full service solution – from idea to market.
04
We act together
We are a team of dedicated professionals who share a passion for always delivering the best suitable solution to our clients. By partnering up and working together, we meet the strict requirements of MedTech compliance as fast, accurate and effective as possible.
05
Strong EU/US foundation
With offices and employees in Sweden (Devicia AB) and US (Devicia Inc) we provide a solid foundation and act as a bridge between EU and US. Whether you are in need of global strategies, expertise for successful market entry or guidance through transition activities – we can assist you.
News Updates & White Papers
A part of the technical committee for laboratory medicine (SIS/TK 331)
Support to SOS Children’s Villages
Attend the virtual #Biodata2Digi workshop
White paper: Economic operators – are you prepared?
Course on Clinical Evaluation & Clinical Investigation for Medical Devices
Learn more about our sister company Kickfile and their journey!
Partners for full-service
Together with Clarvin, Limulus Bio and Kickfile, we support all your needs, everywhere, every time. Irrespective if it relates to Strategic Advice, Quality Assurance, Regulatory Affairs, Clinical Affairs or Biocompatibility.
