Medical Device Record - Part I

Due to the length of this topic, this blog is divided into two sections, I and II.

1)    Basically, Device Master Record (DMR) is a catalog and compilation of device-specific documentation required for the procurement of materials and components, manufacture, and evaluation of the device. DMR is also a compilation of current records and the status of the physical and software  configuration of the device.

A unique DMR is established for each type or model (family) of medical device manufactured by the company.

2)    Types of Documents included in DMR 

For each type or model of medical device, the DMR includes the following types of documents. However, not all types of documents specified in this section are totally relevant for each type or model of device. For a particular device, the individuals responsible for Engineering, Production, Regulatory and QA decide jointly which specific documents are to be included in the DMR.

Note: all these documents should be in the final form, initialed and dated by responsible parties. Each document must have a unique identification for traceability.

2.1.    Device Specifications shall include, but not limited to the
     following:

§  Trade and Common names of the Device;

§  Intended Use/Uses of the Device;

§  Performance Characteristics and Theory of Operation of the Device;

§  Physical Characteristics of the Device like size and weight;

§  Environmental Limitations of the Product;

§  Product Stability of the Product;

§  Storage Requirements like temperature and humidity;

§  User Safety Characteristics;

§  Component, Subassembly and Assembly Drawings and Specifications;

§  Bills of Materials (BOM); BOM must be detail and organized properly;

§  Compositions and Formulations; What type of materials;

§  Wiring, Piping, Electronic and Engineering Drawings;

§  All Related Software Information.

2.2     Manufacturing Process Specifications: This is mainly to
          show how this product is being made, examples are shown
          below:

§  Process Flow Charts, Manufacturing Site and its Flow;

§  Process/assembly Lines Diagrams;

§  Manufacturing Instruction of the Products:

§  Equipment, Tools and Molds requirement to make this product;

§  Manufacturing Environment Specifications such as cleanroom specification;

§  Setup procedures for equipment, tool and molds;

§  Operator Instructions;

§  Equipment Maintenance procedures like preventive maintenance and its schedule.

§  Validation reports for special processes like IQ/OQ/PQ of processes.

§  Sterilization specifications, procedures, and validation reports like Gamma, ETO or E-beam sterilization.

§  Blank work orders, nonconforming product/process forms, and other reporting forms.

2.3     Quality Assurance Procedures and Specifications:

·       Quality System Manual both Hardcopy and Softcopy;

·       Quality System Operational Procedures. There should have many procedures for this operation.

·       Quality System Forms like forms for CAPA and non-conforming products.

·       Process Control Specifications/Charts;

·       Control Plans, Instructions and Acceptance Criteria for Incoming, in-process, and finished device inspection and testing;

·       Procedures and Acceptance Criteria for the Verification of Packaging, Labeling, Installation, and Servicing Activities;

·       Blank Work Order forms for Recording Inspection/testing activities, traceability, and other data for device history records;

·       Device Release Review/evaluation checklists.

2.4     Packaging and Labeling Specifications of Device:

§  Package Drawings and Specifications;

§  Filling/Packaging procedures;

§  Label/Labeling drawings;

§  Instruction or direction for use manuals. This must be the latest and shall be updated as new information becomes available.

2.5     Installation, Maintenance, Training and Servicing
         Specifications:

§  Installation, Specifications and Instructions for the Device;

§  Maintenance Instructions for the device;

§  Servicing Specifications and Manuals.

§  Training Documents.

Reference	Criteria
21 CFR 820.181	Has the company maintained device master records (DMR’s)?
21 CFR 820.181	Has the company ensured that each DMR is prepared and approved in accordance with Document Control requirements?
21 CFR 820.181 (a)	Does the DMR for each type of device include, or refer to the location of, device specifications including appropriate drawings, component specifications, and software specifications?
21 CFR 820.181 (b)	Does the DMR for each type of device include, or refer to the location of, production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications?
21 CFR 820.181 (c)	Does the DMR for each type of device include, or refer to the location of, quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used?
21 CFR 820.181 (d)	Does the DMR for each type of device include, or refer to the location of, packaging and labeling specifications, including methods and processes used?
21 CFR 820.181 (e)	Does the DMR for each type of device include, or refer to the location of, device specifications including appropriate drawings, component specifications, and software specifications, and installation, maintenance and servicing procedures and methods?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.

Design Transfer

Design transfer is another critical phase of the design control of the medical device.  This is the phase of transferring the design into manufacturing or production. The key is to ensure the production specifications are being done right. This is to ensure that the manufactured devices can be repeatedly and reliably produced within product and process capabilities.

Therefore, to achieve that, it is critical to have frequent consultation and intensive interaction especially between design engineering and production engineering.

All must be involved with design review meetings and activities from the beginning to end. Intensive interaction is especially required when the device is new to the production team.

Some examples of production specification are as below:

                  

                  ·       Assembly Drawings

·       Component Procurement Specification

·       Computer-aided Manufacturing (CAM) Programming Files

·       Digital Data Files

·       Inspection and Test Specification

·       Manufacturing Instructions

·       Manufacturing Jigs and Aids

·       Master EPROM

·       Programmable Device Files

·       Prototypes

·       Training Materials

·       Workmanship Standards

Another key element is having a design and development procedure which include a qualification assessment for the completeness and adequacy of the production specifications.

Secondly, the procedures shall ensure all documents and articles regarding production specifications are reviewed and approved by respective team members.

Thirdly, procedures should also ensure that only approved specifications are used in the manufacturing of the medical devices.

I found that it is very useful to have all the documents about production specification into a formal ‘design transfer’ template. This template must contains all the final version of all documents of the design transfer.

 But, unfortunately, I had encountered many medical device manufacturers failed to have a seamless design transfer. For example, design engineering waited until the last minute to transfer to production and expect the medical devices to be produced perfectly. Therefore, it is critical that the manufacturing and production department not to get involved at the last minute.  You just cannot dump the whole design transfer documentation to the production team last minute.                                                                                                                                                                                                                                         

Reference	Criteria
21 CFR 820.30(h)	Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.

Design Validation

The blog is about design validation to ensure the medical device satisfies defined user needs and intended use or uses. Design validation should be performed on initial production units and under simulated or actual conditions in which the medical device will be used.

Design Project Plan should include planning and scheduling of design validation activities. All planned validation activities must be completed with satisfactory result prior to any device can be delivered to the customers.

Designs are validated according to approved and documented protocols. Project manager should be responsible to establish detail of validation protocols. Validation protocols should specify:

·       Acceptance criteria;

·       Clinical Evaluation;

·       Evaluation of Performance of Medical Device;

·       Operating environment and/or conditions;

·       Modes of use;

·       Testing methods, setup and procedure.

                 

Examples of Design Validation activities for medical devices may include the following:

·       Animal testing.

·       Bench testing.

·       Clinical method evaluations in clinical and nonclinical settings.

·       Clinical studies for product to be marketed in the US that approved by IRB and IDE, or by IRB’s only for non-significant risk devices.

·       Clinical studies for product to be marketed in the EU that approved by Ethics Committees and submitted to Competent Authorities.

·       Literature searches on related medical device.

·       Software Validation to include software validation protocol.

·       User acceptance testing.

·       Review of labels and labeling, packaging, and other historical product information.

·       510(k) or PMA historical database searches.

All design validation activities are always documented in design validation reports. For example, forms, report etc for recording data and reporting results are included in design validation protocols. All design validation records include the date when the validation was carried out and the name of the individual(s) or the third party organization like Contract Research Organization (CRO) performing the validation.

During design validation, when the device does not meet requirements and the design must be modified or corrected, the necessary actions required to correct the problem are documented and their implementation is recorded. This may be in minutes of design reviews, memo, in validation reports and studies, or as notes or mark-ups made directly on design output documents.

Sample of design validation records are:

·       Validation methods and protocols with validation results,

·       Actions necessary to address problems, and their associated reports,

·       Identification of individual(s) or CRO and dates performing validation,

·       Software validation method, protocols and results like reports with a lot of screen shots.

·       All protocols and reports must have their respective unique identities to avoid confusing later.

Irrespective of their nature and format, all design validation records include the date, name of the individual(s) performing the validation, records identity number, actual validation report, memo etc are maintained in the Design History File (DHF).

Reference	Criteria
21 CFR 820.30(g)	Does the company establish and maintain procedures for validating the device design?
21 CFR 820.30(g)	Is design validation performed under defined operating conditions on initial production units, lots, or batches, or their equivalents?
21 CFR 820.30(g)	Does design validation ensure that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use condition?
21 CFR 820.30(g)	Does design validation include software validation and risk analysis, where appropriate?
21 CFR 820.30(g)	Are results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, documented in the DHF?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.

  

Design Verification

This blog talks about design verification. The main purpose of design
verification is to ensure design outputs met design input requirements.

Design Input = Design Output

Design verifications can be carried out at various phases of the design and can applied to individual components or subsystems as well as the whole design. This verification strategy is to ensure that any one phase or from one subsystem is verified before it is used as design input in the next phase or for another subsystem.

The project manager decides which verification methods are deployed to verify design outputs. Verification method deployed shall be the most appropriate for that subassembly, component or the whole device. Examples of commonly used design verification methods are shown below:

Analysis, Calculations, Checks, Comparisons with similar proven designs, FMEA (Failure Mode and Effects Analysis), Measurements, Studies, Simulations, Tests, Thermal Analysis and Reviews.

Results of these verification reviews are documented in the minutes of design review meetings. If there are distinct design verification activities, such as studies, analyses, calculations and tests are planned and scheduled in the Design Project Plan. Results of these verifications are usually documented in special reports. Records of these verifications are the approval and release signatures on design output documents.

Should there a case when the design does not meet requirements and must be modified or corrected, all necessary actions to rectify the problems are documented and their implementation is recorded clearly and in detail.

As usual, all design verification records include design review minutes, date of the verification, the name of the individual(s) performing the verification, attachment of any verification reports, special reports, studies etc are maintained and updated in the Design History File (DHF).

Reference	Criteria
21 CFR 820.30(f)	Has the company established and maintained procedures for verifying the device design?
21 CFR 820.30(f)	Does design verification confirm that the design output meets the design input requirements?
21 CFR 820.30(f)	Are he results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, documented in the DHF?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.