The Most Important Compliance Best Practices You Need to Know

The Food and Drug Administration (FDA) requires manufacturers of medical devices to create and maintain a device master record (DMR). Section 820.3(j) of the Federal Code defines device master record. DMR is a set of documents containing procedures and specifications for a finished medical device. 

This article gives the best practices for maintaining DMR to comply with medical device regulations.

The guidance contained within this document is intended to apply to medical devices generally and combination products regulated as medical devices. It is not intended to cover in vitro diagnostic medical devices. Additionally, this document was drafted primarily to address the use of Clinical Investigations to support a marketing authorization application. Some aspects of this document may apply to studies conducted following commercial release of a device. Future GHTF documents will specifically address post-market clinical follow-up studies.

This document provides guidance on

• when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Principles (see GHTF/SG1/N041 – “Essential Principles of Safety and Performance of Medical Devices”); and
• the general principles of clinical investigation involving medical devices

Sections

• General Principles When Considering the Need for a Clinical Investigation
• General Principles of Clinical Investigation Design
• Ethical Considerations for Clinical Investigations

This document provides guidance in relation to:

1. the circumstances where a post-market clinical follow-up study is indicated;
2. the general principles of post-market clinical follow-up studies involving medical devices; and
3. the use of study information, including, for example, to provide information to update labelling.

This document does not apply to in vitro diagnostic devices.

It explains -

• The Circumstances Where A Post-Market Clinical Follow-Up Study Is Indicated
• The Elements Of A Post-Market Clinical Follow-Up Study
• The Use Of Study Information

This document is intended to provide guidance on the content of the STED to be assembled and submitted to a RA or CAB for premarket review, and for use post-market to assess continuing conformity to the Essential Principles of Safety and Performance.

The availability of such Summary Technical Documentation (STED) should help eliminate differences in documentation requirements between jurisdictions, thus decreasing the cost of gaining regulatory compliance and allowing patients earlier access to new technologies and treatments.

Major Sections of this document

6.0 Device Description and Product Specification, Including Variants and Accessories
6.1 Device Description
6.2 Product Specification
6.3 Reference to similar and previous generations of the device
7.0 Labelling
8.0 Design and Manufacturing Information
    8.1 Device Design
    8.2 Manufacturing Processes
    8.3 Design and Manufacturing Sites
9.0 Essential Principles (EP) Checklist
10.0 Risk Analysis and Control Summary
11.0 Product Verification and Validation
    11.1 General
    11.2 Biocompatibility
    11.3 Medicinal Substances
    11.4 Biological Safety
    11.5 Sterilisation
    11.6 Software Verification and Validation
    11.7 Animal Studies
    11.8 Clinical Evidence
12.0 Format of the STED
13.0 Declaration of Conformity

This document describes:

• the evidence and procedures that may be used by the manufacturer to demonstrate that a medical device is safe and performs as intended by the manufacturer and conforms to the Essential Principles of Safety and Performance for Medical Devices;
• the conformity assessment elements that should apply to each class of device such that the regulatory demands increase with the risk class of the medical device;
• the process by which a RA, or CAB appointed by or acting on behalf of the RA, may confirm that such elements are properly applied by the manufacturer; and
• the manufacturer’s written attestation that it has correctly applied the conformity assessment elements relevant to the classification of the device, i.e. the ‘Declaration of Conformity’.

The definitions and concepts contained within this document are intended to apply to the establishment and maintenance of conformity with the relevant Essential Principles for medical devices generally. Specific guidance will be developed in other documents in relation to in vitro diagnostic devices. Similarly, guidance about how to generate, compile and present clinical evidence for the purpose of demonstrating compliance with the Essential Principles for safety and performance of a medical device will be addressed in future documents.

This document provides guidance to manufacturers and Regulatory Authorities on medical device labelling that clearly informs the user of:

• its identity and intended use/purpose;
• how it should be used, maintained and stored;
• any residual risks, warnings or contra-indications;

Also it promotes

• labelling commensurate with the technical knowledge, experience, education or training of intended users;
• use of symbols.
• the avoidance of prescriptive country-specific requirements for labelling text, content, or the format of labels or labelling that offer no user or patient benefit

Sections:

Definitions
Labelling Requirements
 - General Principles
 - Content of Labelling

This document describes six general requirements of safety and performance that apply to all medical devices.
It provides a comprehensive list of design and manufacturing requirements of safety and performance, some of which are relevant to each medical device. These are grouped as:

• Chemical, physical and biological properties.
• Infection and microbial contamination.
• Manufacturing and environmental properties.
• Devices with a diagnostic or measuring function.
• Protection against radiation.
• Requirements for medical devices connected to or equipped with an energy source.
• Protection against mechanical risks.
• Protection against the risks posed to the patient by supplied energy or substances.
• Protection against the risks posed to the patient for devices for self-testing or selfadministration.
• Information supplied by the manufacturer.
• Performance evaluation including, where appropriate, clinical evaluation

This guidance describes how certain provisions of the medical device Quality System regulation apply to software and the agency’s current approach to evaluating a software validation system.  For example, this document lists elements that are acceptable to the FDA for the validation of software; however, it does not list all of the activities and tasks that must, in all instances, be used to comply with the law.

The scope of this guidance is somewhat broader than the scope of validation in the strictest definition of that term.  Planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering discussed in this guidance are important activities that together help to support a final conclusion that software is validated.

This guidance recommends an integration of software life cycle management and risk management activities.  Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine the specific approach, the combination of techniques to be used, and the level of effort to be applied.   While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle.Where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) the software developer may not be directly responsible for compliance with FDA regulations.

In that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developer’s activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturer’s intended use.

This guidance applies to:

• Software used as a component, part, or accessory of a medical device;
• Software that is itself a medical device (e.g., blood establishment software);
• Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
• Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

Various sections of this Guidance:

• CONTEXT FOR SOFTWARE VALIDATION
• PRINCIPLES OF SOFTWARE VALIDATION
• ACTIVITIES AND TASKS
• VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE

This document supersedes Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 29, 1998, and Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software, issued January 13, 1997.

This guidance document is intended to provide information to industry regarding the documentation that we recommend you include in premarket submissions for software devices, including stand-alone software applications and hardware-based devices that incorporate software.  This document is a result of ongoing efforts to state our recommendations more clearly and ensure they remain current as technology advances.  This document also combines into one guidance recommendations previously included in two guidance documents.

Disciplined Engineering and project management processes help companies improve processes and techniques. This could be the key factor when one company can churn out similar products faster than it competitor. Quality, speed and cost-efficiency are the measures of success for any engineering project. But in reality, one is achieved at the expense of the other. Quality and speed can be achieved but at higher costs. Cost-efficiency can be achieved but quality may be compromised.

Quality is perceived differently by people concerned. The challenge is to meet these expectations and make the product a success. Speed also requires certain considerations with regards to process, resources etc.

How to reign in these factors of quality, speed and cost and role of regulatory acceptance read on

Bringing cost effectiveness into the manufacturing of medical devices today is the primary focus of manufacturers. Testing becomes the key for compliance with the quality system requirements. Testing has become a critical aspect when it comes to achieving the desired quality of products.

Testing includes:

• Design testing
• Verification of embedded software
• Design validation
• Critical agency testing
• Electromagnetic compliance

To know more on implementation of session based testing, read on