Your Medical Device CRO
Devicia is your full-service CRO, supporting you throughout the life cycle of your medical device and In Vitro Diagnostic (IVD). 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 and IVD Expertise
- Offices in Sweden and the US
- Market focused – public and private clients
Medical Device and In Vitro Diagnostic Regulation
Make sure your medical device and IVDs complies to the new EU Medical Device Regulation, MDR 2017/745 and IVDR 2017/746.
Let us help you – you will have a smooth transition to the new regulation.
Full-service solutions for medical devices and IVDs - examples of our services are listed below:
Let us navigate you through the regulatory landscape throughout the life cycle of your medical device and IVD. 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 and IVD directive to the new EU regulation, we are here to support you.
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.
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.
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.
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
Medical Device & IVD Exclusivity
Our medical device and IVD 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.
As members of the technical committees and nominated as experts in international working groups writing medical device and IVD standards, we can provide you with an insight perspective.
Full service CRO
We have extensive medical device and IVD experience within Quality, Regulatory and Clinical Affairs. We are dedicated to provide you with a full service solution – from idea to market.
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 as fast, accurate and effective as possible.
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
Strengthen the Future of Life Science
A vibrant evening at GoCo Health Innovation City
GoCo House Welcomes MedTech-Exclusive Advisors to GoCo Health Innovation City
New EU regulation for in vitro diagnostic medical devices (IVDR 2017/746)
Swedish government’s proposal for an Official Report regarding the use of health data
IVDR training with Kickfile
Our ecosystem for full-service medical device compliance
We are your full-service medical device partners. Together we offer unique expertise regarding Quality Assurance, Regulatory Affairs, Clinical Affairs, Biological Evaluations & Toxicology.