Medra+ is a Regulatory Affairs, QA and Clinical Affairs consultancy firm, with proven expertise and skills for the last 20 years in the field of Global Regulatory Affairs of medical devices, IVD’s, drugs & pharmaceutical products and cosmetics. We assist in Design & Development, ISO 13485, QMS Compliance, Technical file writing including CER writing, 510k submissions, CE (MDR/IVDR) approval arrangement and Asia registrations. Our goal is to help our clients to achieve their sales in a very cost-effective way by integrating and understanding of international regulatory requirements. We are specialized in QA, Regulatory Strategy and Clinical Affairs consultancy.
Company Details
- Employees
- 5
- Founded
- -
- Address
- 10 Ubi Crescent (Lobby C), #07-43,ubi Techpark,germany
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- https://medrasg.com/
- Keywords
- Medical Device, CER, Technical file, ISO 13485, QMS Implementation and Audit, 510k, MDR, IVDR, CE, Clinical trial, CRO, HSA, MDA Malaysia, Product registration, Risk Management, Clinical Evaluation Report, Usability, Validation, Software Validation, Medical Writing, Design and Development, Medical Device Software Documentation, GSPR, Training, GMP.
- HQ
- SINGAPORE, SINGAPORE
Medra+ Pte Ltd Questions
Medra+ Pte Ltd's website is https://medrasg.com/
Medra+ Pte Ltd's LinkedIn profile is https://www.linkedin.com/company/medra-pte-ltd
Medra+ Pte Ltd has
5 employees.
View email and phone details for 5
employees at Medra+ Pte Ltd.
Medra+ Pte Ltd's industry is
Medical Equipment Manufacturing
Medra+ Pte Ltd's top competitors are
Genip,
Global Healthcare Sg,
Namsa,
Sebia Singapore,
Phoelia (Far East) Co. Ltd,
Microtherm North America Inc.,
Tamilnadu Chamber Of Commerce And Industry,
Enmed,
Merto Software Solutions,
Hicura Medical Pte Ltd.
Medra+ Pte Ltd's categories are Medical Equipment Manufacturing
Medra+ Pte Ltd's founding year is 2015
