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CLINICAL INVESTIGATIONS 

Devicia provides full-service clinical investigation consultancy services to help you generate clinical data, both prior to and after market introduction of your medical device. Our team will help you to effectively integrate your clinical investigations into your go-to-market model. This includes all kinds of investigations, such as first-in-human studies, feasibility or pilot studies, randomized controlled clinical investigations, and registries. 
 
Devicia’s aim is to provide services that enable your company to make patients benefit from your device as quickly and safely as possible. When working with us, you get access to a team that specializes exclusively in clinical investigations for medical devices.

Furthermore, our Quality Management System (QMS), based on ISO 14155, is specifically tailored to the requirements for clinical investigations of medical devices. When designing clinical investigations, we always consider the reimbursement landscape in order to make the device available to as many consumers as possible. 
 


Our services include: 

- Clinical Investigation Documentation (ISO 14155, MDD 93/42/EEC, MDR 2017/745, 21 CFR parts 50, 56, and 812)
  (CIP), Investigator’s Brochure (IB), Patient Information Sheet (PIS) and Informed Consent Form (ICF),
- EC/IEC/IRB and CA/RA submissions
- Study and Site Files
- Data Management
- Biostatistics
- Monitoring
- Site Selection, Site Initiation and Close-out Visits
- Project Management
- Recruitment Material 
- Audits

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About Us

Your goal is to achieve fast and predictable market access.
Our goal is to help you place your medical device quickly and safely in the hands of those who will benefit from your innovative technology.
 
Let us guide you through all the steps needed for your clinical studies and make your journey from study idea to fully executed study swift, transparent and agile.
 
With extensive medical device experience within Quality, Regulatory and Clinical Affairs, and a team of experts on staff, we provide full service solutions to our clients - from idea to market. As members of technical committees and nominated as experts in international working groups writing medical device standards,  we provide our clients with an industry perspective and first-hand advice.

CONTACT US:      +46 72 55 56 891 - info(@)devicia.se - or   ►

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Sweden - Mölndal

+46 72 55 56 891

Address:
Argongatan 2C,
SE-431 53 Mölndal
Sweden

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Sweden - Stockholm

+46 72 55 56 891

Address:
Brunnsgatan 6
SE-111 38 Stockholm
Sweden

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USA - PA

+1 484 803 24 14

Address:
1735 Market Street
Suite 3750, Philadelphia
PA 19103, USA








Copyright © 2019 Devicia.  All rights reserved.