MedScrum

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’s Keywords:

internal auditing, quality, training, samd, software as a medical device, regulatory, mdl, mdel, hipaa, 510