MedScrum is a resourceful & innovative regulatory affairs, quality assurance and HIPAA compliance consultancy in the global MedTech industry
We position regulatory & quality as revenue drivers to help our clients achieve their unique business goals
Services
Regulatory
*Prepare FDA 510(k) submissions (Traditional, Abbreviated, Special)
*Prepare & facilitate Class II and III Health Canada device license applications (MDLs)
*Facilitate product CE Marking
*Prepare medical device technical files
*Prepare Medical Device Establishment License (MDELs applications and amendment)
*Perform FDA Establishment Registration and Device Listing Activities
Quality
Develop from scratch or augment existing quality management systems for US, EU, and Canadian-based medical device manufacturers in keeping with:
*EN ISO/ISO 13485:2016
*Canadian Medical Devices Regulations (CMDR)
*Medical Devices Directive (MDD 93/42/EEC)
*Australian Therapeutic Goods Administration (TGA)
*JPAL (Japan)
QMS Policy & Procedure Development
Design, author & facilitate the implementation of new & revised QMS policies and procedures with respect to:
*Supplier Management
*Internal Auditing
*Management Reviews
*Corrective & Preventive Action
*Complaint Handling, Recalls, Medical Device Reporting
*Design and Development
*and more
QMS Training
Deliver customized training with respect to:
* ISO 13485:2016 (and EU equivalent)
*21 CFR Part 820 (FDA QSR)
*IEC 62304:2006/AMD 1:2015
*Health Insurance Portability and Accountability
*EU-U.S. Privacy Shield
*DMR, DHR, DHF and EU Technical File
*EN ISO/ISO 14971 and Risk Management (tradition, usability, and cybersecurity hazards)
*Design Control
Information Security Management System Development
Develop from scratch or augment existing Information Security Management Systems for traditional medical device manufacturers
Regulatory Intelligence
Keep you aware of the latest regulatory developments
Contact us to learn more
Company Details
- 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
- medscrum.com
Medscrum Questions
Medscrum's website is medscrum.com
Medscrum's LinkedIn profile is https://www.linkedin.com/company/medscrum
Medscrum's industry is
Medical Equipment Manufacturing
Medscrum's top competitors are
Insiteone, Llc,
Vida,
Medx Health Corp.,
Densitas Inc.,
Newvue.ai,
Tepha, Inc.,
Vitamed-Biomedical Srl,
Diamed Lab Supplies Inc,
Imaging Biometrics, Llc,
Precision Biologic.
Medscrum's categories are Medical Equipment Manufacturing
