FDA CDRH, EU-MDR, Global Data Standards
Category: pharmaceutical consulting firms
Start Up, Substantial Equivalence (SE), De Novo, and EU-MDR/IVDR Devices have high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply.
Effective and consistent use and application of Data Standards can reduce the Design Control-Device and Process Development costs of SE, De Novo, and EU-MDR/IVDR Devices via proactive, early utilization of 510k Consultants, Medical Device Consulting, EU-MDR/IVDR Consulting, and effective Q-Sub Meetings collectively resulting in FDA Clearance/Approval.
The purpose of the term “Data Standards”, as used by the FDA is to:
- Develop well-defined, publicly available data standards
- Ensure that data is submitted according to publicized standards
- Develop Advanced review tools so that FDA reviewers can use standardized data efficiently and effectively (example: FDA CARB, etc).
Use of Data Standards enable the seamless integration across and within each step in the Medical Device Design Control and Manufacturing Development Lifecycle for your individual Device(s) as well as any SE Device(s).
The seamless use of Data Standards also require compliance with Data Integrity Standards. Seamless application of Data Standards begins no later than the Design Controls: Design Planning and/or EU-MDR 2017 Annex I and continues throughout all other Design Data, Device History File content and that compiled in the 510/submission.
As a result proactive utilization of Data Standards and Data Integrity expertise via proactive, early utilization of 510k Consultants, Medical Device Consulting, EU-MDR/IVDR Consulting, and effective Q-Sub Meetings are essential to collectively result in FDA Clearance/Approval.
Proactive utilization of Data Standards and Data Integrity expertise via 510k Consultants, Medical Device Consulting, EU-MDR/IVDR Consulting, and effective Q-Sub Meetings will compliantly accelerate your seamless Device/Design Data-Safety-Effectiveness-Risk-Rationale-Justification integration across and within each step in the Medical Device Design Control and Manufacturing Development Lifecycle for your individual Device(s) as well as any SE Device(s). essential to collectively result in FDA Clearance/Approval.
William E. Spanogle, Ph.D. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA (GCP, GLP. GMP), EU-MDR, Design Controls. QMS, PMS, CSV/CSA, and R&D experience. He is a published ISPE Invitational author in Pharmaceutical and Biologics Product and Process Development and has presented and trained thousands of professionals on QbD, Design Controls, Science-Risk Based Product Characterization, and Risk Management at several international conferences and numerous private corporate sessions. Dr. Spanogle has taken scores of Regulated Life Science Products from discovery to pre-clinical and clinical trials, to approval and launch; and audited, identified, and remediated QMS deficiencies.
The opinions and statements in this blog are those of the authors and do not necessarily reflect those of BRG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.
tagging: EU-MDR/IVDR Devices