--Gap analysis audit --Pre-assessment audit --Full or partial internal audit --Subcontractor or supplier audit --Document and records control --Training on regulatory requirements and internal procedures --Design and development --Risk management --Software development (if applicable) --Supplier eval...
As globalization of medical device supply chains has continued to increase, regulatory bodies have grappled with how to bridge the gap between domestic and foreign regulation. Without a unified approach to both, the daily practice of ensuring that regulatory processes are followed and properly docume...
White Paper Preparing for the Medical Device Single Audit Program (MDSAP) The Medical Device Single Audit Program (MDSAP) is a global initiative designed to harmonize regulatory efforts around the world. But despite looming deadlines, comparatively few medical device companies have a meaningful underst...
Medical Device Single Audit Program (MDSAP) Internal Auditor Training Medical Device Complaint Handling, Event Reporting, and Recall Management Training EU MDR CER (Clinical Evaluation Report) Training for Medical Devices Medical Device Software Development Life Cycle (SDLC) and IEC 62304 Training ...
Increasing the Value of Audit Programs with Performance Based Auditing Becoming an Effective ISO 13485:2016 Auditor 101 Oriel STAT A MATRIX’s Goal Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes ...
(FDA, MDSAP, ISO, etc.) at all types of medical device companies (specification developers/designers, sterilization facilities, manufacturers, contract manufacturers/suppliers). In addition, our unique risk-based audit reporting approach provides our clients with actionable priorities in addressing any ...
Learn and Explore Pharmaceutical Guidelines, FDA, ICH, WHO Guidelines, Pharma Production, Quality Control, Quality Assurance, Pharma Audit, and Pharmaceutical SOPs. Email: Contact@pharmaguddu.com
Increasing the Value of Audit Programs with Performance Based Auditing Medical Device Manufacturer Untangles Supply Chain Issues and Addresses FDA Concerns with Help from Oriel STAT A MATRIX Becoming an Effective ISO 13485:2016 Auditor 101 Oriel STAT A MATRIX’s Goal ...