Device Master Record – DMR
Information & Training. | Medical Device Validation, Regulation, …The requirement for a Device Master Record is outlined in the FDA’s Quality System Regulations (QSR’s), per section 21 CFR 820.3(j).
The FDA define general requirements for records, which include their accessibility, location of storage, confidentiality expectations and retention times.
Specifically, the FDA identify the necessity for creating and maintaining a Device History File, Quality System Records, Complaint Files and a Device Master Record.
Device Master Record – DMRThe DMR needs to be developed for each “type” of medical device and will include the following information as a minimum:
The approved, released specifications for the finished device. This includes details of the all components, all software, any applicable formulation and composition.
Specifications for the production processes utilized, which includes methods of production, details on process, measurement and test equipment, operating and test procedures, and environmental specifications.
Quality Assurance test, measurement and operating procedures, quality assurance and quality control acceptance criteria, also details on all quality related test and measurement equipment.
Specifications and operating procedures on all device packaging.
Specifications, procedures and examples of all labelling.
Operating procedures and methods applicable to product installation, maintenance and service.
Examples of the type of information to be recorded into the DMR.
Related to the production processes:
Process & Equipment specifications. Production methods & procedures. Environmental specifications. Validation & Verification reports.Related to the device itself:
Device drawings. Details on formulation & composition. Component & Software specifications. Risk Analysis methods and reports.Packaging and Labelling:
Packaging specifications. Applicable drawings. Methods and packaging procedures.Quality Management System:
Quality procedures. Quality specifications. Test and acceptance criteria. Test and measurement equipment.Change Management:
Change requests. Change review & approval records. Verification & validation reports related to changes. Change risk assessment.Installation and Maintenance:
Servicing and maintenance procedures. Quality control procedures. Acceptance criteria.
FDA CFR Part 820: Quality System Regulation.
Sec. 820.181 Device master record.
Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
(d) Packaging and labeling specifications, including methods and processes used; and
(e) Installation, maintenance, and servicing procedures and methods.
Information & Training.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- NewEuropean Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- Information & Training presentation >>>
CFR – Code of Federal Regulations Title 21. Part 820. QSR. Records.