In the medical device industry, precision and clarity in communication are crucial due to the high stakes involved in terms of patient safety and regulatory compliance. Misunderstandings can lead to errors that may have serious ramifications, highlighting the importance of a thorough understanding of industry-specific terminology and acronyms.
To assist professionals in navigating the complex landscape of medical device production and marketing, a comprehensive list of medical device acronyms has been compiled. This resource is invaluable for ensuring efficient workflow and clear communication among industry stakeholders, and it is readily accessible for reference in a printable PDF format.
Key Medical Device Regulations and Terms:
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21 CFR Part 11 and 21 CFR Part 820:
- 21 CFR Part 11: This regulation by the FDA outlines the criteria for acceptance of electronic records and signatures, which is crucial for maintaining compliance in digital documentation.
- 21 CFR Part 820: Establishes quality system regulations for medical device manufacturers in the U.S., mandating the creation and maintenance of a quality system suited to the specific devices being manufactured to ensure their safety and efficacy.
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483 Observation and 510(k) Premarket Notification:
- 483 Observation: An FDA notice indicating potential regulatory violations during inspections.
- 510(k) Notification: A regulatory submission to demonstrate that a new medical device is safe and effective as it is substantially equivalent to a legally marketed device.
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Auditing and Compliance Acronyms:
- ALM (Application Lifecycle Management): Involves managing the software development lifecycle to ensure quality and compliance.
- AO (Auditing Organization): Entities that audit medical device manufacturers to check conformity with regulatory requirements.
- ASL (Approved Supplier List): A record maintained by manufacturers listing suppliers that meet quality standards.
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Design and Documentation Control:
- BOM (Bill of Materials): Lists all materials and components needed for device manufacture.
- CAD (Computer-Aided Design): Software used for detailed design of devices.
- CAPA (Corrective and Preventive Action): A process to identify and eliminate sources of quality risks.
- DHF (Design History File) and DMR (Device Master Record): Documentation that outlines the design process and specifications for manufacturing a medical device.
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Quality Management and Regulatory Compliance:
- QMS (Quality Management System): A framework for documenting processes, responsibilities, and procedures required to achieve effective quality management.
- ISO Standards: International standards such as ISO 13485:2016 for quality management systems and ISO 14971:2019 for risk management.
- CE Marking: Indicates that a medical device meets the requirements of European health, safety, and environmental protection standards.
- Other Critical Acronyms:
- MDR (Medical Device Reporting): A system for reporting the performance and safety of medical devices post-market.
- PMA (Premarket Approval): The FDA process for reviewing and approving Class III medical devices before they can go to market.
- V&V (Verification and Validation): Processes to ensure the device was designed correctly and that it meets the intended use requirements.
Resource Accessibility and Future Learning:
The availability of such a databank of acronyms and terms significantly streamlines the process of integration and compliance for professionals involved in the medical device sector. It is recommended for practitioners to bookmark this reference resource for continuous access during their work operations. Additionally, for deeper insight and guidance, following links to extended guides and exploring platforms like Greenlight Guru’s blog can provide expanded knowledge and understanding of specific topics detailed in the list.
In a sector where regulatory compliance and device efficacy and safety are paramount, having such quick access to crucial terminology and regulatory frameworks through comprehensive lists and educational resources equips medical device professionals with the tools necessary for success in a competitive and highly regulated market.
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