This Blog speaks about harmonization of FDA QSR and ISO 13485. Those who are new to the industry probably have so many questions like How do we start? Which Regulations need to follow? what is QSMR?
To begin with, we will first understand QMS. Quality Management system covers designing, manufacturing, structuring, risk management, product labeling, clinical data, storage and more. ISO 13485 Certification for Medical devices is a quality management system required for regulatory purposes.
QMSR-(Quality Management system regulation Explained)
QMSR Explained: What FDA QSR and ISO 13485 Harmonization means for Medical Device Companies
After the Four years, the US Food and Drug Administration (FDA) signalled its intent to align its Quality System Regulation (QSR) with the international standard ISO 13485:2016.
As per the FDA’s rule proposed on February 23,2022 for the new QMSR, The proposed QMSR will be the outcome of integrating the FDA’s Quality System Regulation (QSR) regulations for current Good Manufacturing Practices (cGMP) with ISO 13485:2016, the international consensus standard for medical device quality management systems. According to FDA’s analysis, the regulation as written would result in a cost savings of $439-533 million over 10 years for medical device establishments that comply with both standards.
Contact details –
Phone no - 9325283428Mail - dm@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.- Medical Device Consulting
- cdsco registration
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- TURNKEY PROJECT CONSULTANT
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- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
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