Medical Devices Validation, Regulation, Compliance.

Information & training presentation.
The design, manufacture, processing of medical devices, demands an understanding of the various medical device regulatory requirements and international standards, e.g. FDA Process Validation requirements, ISO 13485, ISO 14971, etc..  How are medical devices classified? How do you integrate risk into the validation process? How do you perform a validation gap analysis? How is validation effectively performed during product design? How to validate a medical device containing software? Etc., etc..

Details on how to access, etc. … >>>

CONTENTS of currently available Medical Device information & training presentation.  

Introduction to regulatory requirements and international standards.

The key US and European regulations related to Medical Devices. Expectations for requirements such as the FDA’s 21 CFR Part 820. Basic Principles, Concepts, Terms & Definitions related to Validation.


How to implement Medical Device Process Validation.

Implementation of Production & Process Controls. When do you need to Validate a process (versus Verification). Examples of processes that should be Validated. Examples of processes that may be Verified. How do I know if a process cannot be fully Verified?


US FDA approach to Medical Device Regulation.

Establishment registration, 510(k), PMA, Labeling, …..


US FDA Medical Device Classification.

FDA classification structure, approval requirements, 510(k) predictive device equivalence determination, ….


Medical Device Regulation in Europe.

The key Medical Directives. Roles and responsibilities of the Notified Bodies, Competent Authorities, Authorized Representatives. The 10 stages to medical device product approval and “CE” certification.


ISO 13485 Medical Devices – Quality Management Systems.

Review of requirements. This standard was published (officially updated) on 1st March 2016. Information on the changed areas of focus inherent in the new revision.


Software Validation for Medical Device products and processes.

Guidance for Software Validations. Categories of Software. The Software Life Cycle. User Requirements Specification. Software Design Specifications. Integration and Acceptance Test Specifications. Verifying Test Steps. Expected Outputs and Evaluation Criteria. Extent of software validation to be performed.


Implementation of a compliant Medical Device design and development process.

Quality System Requirements for Design Controls. Design Input & Output, Expectations, Regulations & Examples. Rationale for Design Control Requirements. The Process of Design Control. Design and Development Planning. Design Input types, sources, considerations, etc.. Design Output expectations. Performing Design Reviews. Creating and maintaining the Design History File.


The Life Cycle Approach to Validation.

Implementing a Life Cycle Approach. Installation Qualification (I.Q.). Operation Qualification (O.Q.). Pre-Validation Study (PVS). Performance Qualification (P.Q.).


Implementing an on-going revalidation process.

Revalidation and Change Control. Review and evaluation of revalidation. Significance of “where appropriate” in revalidation.


Creating a comprehensive Validation Master Plan (VMP).

The Validation Master Plan (VMP) development process. Why is a VMP necessary? Who prepares and approves the plan? How do you prepare & assemble a plan? Elements of a Validation Master Plan. Implementation of the VMP.

Medical Device Validation FDA, EU. Sample page. View more pages >>> >>>

Sample page. View more pages >>> >>>

How to perform a Validation Gap Analysis.

The role of gap analysis. How to plan and develop a gap analysis to assess compliance. Typical assessment Tools and Techniques. Determining the methodology to use. Preparing for issues that may be found. Applying risk-based re-mediation.


Current Good Manufacturing Practices (cGMP’s).

Principles of current Good Manufacturing Practice (cGMP). The concept of a device being “fit for intended purpose”. The FDA Quality System Regulations (QSR’s) explained.


The key validation related components of an effective Quality Management System.

… Documentation.  Determining the necessity for documentation. Review of the various types of documentation. Implementing and maintaining compliant Standard Operating Procedures. Understanding the fundamental documentation rules. Maintaining a controlled documentation process.


How to identify the need for Validation based on identifying and quantifying Risk.

Why use a risk based approach? Considerations of the ISO standard to Risk Management, i.e. EN ISO 14971. What are the various Risk Assessment Tools and Techniques. The suitability of the various techniques to assessing risk.


Planning, documentation and reporting validation protocols.

Qualification Report content. Protocol Report summary. Data Analysis summary. Exception statements.