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REGULATORY AFFAIRS 

Regulations for medical devices differ substantially from those of pharmaceutical and drug development. With a high level of proficiency in Regulatory Affairs and extensive experience with EU and US medical device regulations, we are able to support you in handling challenges and questions arising throughout your medical device life cycle and help your company navigate regulatory requirements. 
 
Devicia is a member of multiple committees and trade organizations both in the EU and the US. As a nominated expert in the ISO/Technical Committee 194 Working Group 4, Devicia works with the globally recognized ISO 14155 standard governing clinical investigations of medical devices in humans. Thus, we can provide you with the very latest insights on new regulations, as well as delivering strategic input for future trends in medical device requirements.
 


Our services include: 

- Clinical Quality Management Systems (ISO 14155)
- Audits
- Strategic Advice
- Education
- Clinical Regulatory Affairs
- Clinical Due Diligence
- Clinical Regulatory Guidance, such as gap analysis and interpretation of clinical data requirements
- Project Management
- Clinical Regulatory Expertise
- Clinical Development Strategy

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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 72-555 68 91 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








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