Pure Global - Medical Device Regulatory Consulting Company

About Pure Global

Pure Global is a medical device regulatory consulting company, certified under the BSI ISO13485:2016 quality management system. Our experienced team, many of whom possess Regulatory Affairs Certification (RAC), uses their extensive industry knowledge and international expertise to help our clients expand globally.

As a leading authority in regulatory matters for medical devices and invitro diagnostics, we are proud of our globally dispersed consulting team, who are all certified in regulatory affairs and possess significant clinical experience. Our ISO 13485 certification underscores our dedication to offering expert advice amidst a complex global regulatory environment.

Introducing new products to the market can be complex, and we are here to assist. We maintain a strong network of clinical sites and biobanks to back your clinical and regulatory needs. We provide a comprehensive array of services including:

* Regulatory Support
* Clinical Trial Support
* In-Country Representation
* Post Market Surveillance
* Biocompatibility Testing, Packaging Testing & Sterilization validation
* AI & Data Tools
- Market Intelligence
- Latest Regulatory Updates
- Clinical Research Database
- Global Distributor Database
- Certification Management

Market access: Global Representation & Registration Services

United States of America: United States FDA Medical Device Registration
United Kingdom: United Kingdom MHRA Medical Device Registration
European Union: CE Marking Certificate for Medical Devices
Argentina: ANMAT Argentina Medical Device Registration
Australia: TGA Australia Medical Device Registration
Bangladesh: DGDA Bangladesh Medical Device Registation
Brazil: ANVISA Brazil Medical Device Registration
Canada: CMDR Canada Medical Device Registration
China: NMPA China Medical Device Registration
Colombia: INVIMA Colombia Medical Device Registration
Egypt: EDA Egypt Medical Device Registration
Hong Kong: MDD Hong Kong Medical Device Registration
India: CDSCO India Medical Device Registration
Indonesia: MOH Indonesia Medical Device Registration
Israel: MOH Israel Medical Device Registration
Japan: PMDA Japan Medical Device Registration
Malaysia: MDA Malaysia Medical Device Registration
Mexico: COFEPRIS Mexico Medical Device Registration
Pakistan: DRAP Pakistan Medical Device Registration
Peru: DIGEMID Peru Medical Device Registration
Philippines: FDA Philippines Medical Device Registration
Saudi Arabia: Saudi Arabia SFDA Medical Device Registration
Singapore: HSA Singapore Medical Device Registration
Swtizerland: Swissmedic Switzerland Medical Device Registration
Taiwan: FDA Taiwan Medical Device Registration
Thailand: FDA Thailand Medical Device Registration
United Arab Emirates: MOHAP UAE Medical Device Registration
Vietnam: Vietnam MOH Medical Device Registation

Company Details

Address: 111 Town Square Pl, Suite 1203, Jersey City, New Jersey 07310, US

Phone Number: 1-888-768-1688