ISO 13485 Training, Medical Devices, Internal Auditor, Lead Auditor,Overview
driving worldwide business excellence
Automotive & Production/ Manufacturing Core Tools

Australian TGA Medical Device Regulations

Advertising - Medical Devices
Guidelines for advertising medical devices in Australia.

Alternative Therapies
Using medical devices in non-conventional therapies.

Animal Material, Devices Using
Minimizing risks associated with Transmissable Spongiform Encephalopathies (TSE).

Application Audits, Medical Devices
Requirements before an application can be filed, product audits, contents, etc.

Boundary Products
Talks about distinctions between medical devices and medicines. Provides examples.

Clinical Evidence Requirements
Role of clinical evidence, data generation, requirements of a clinical evaluation.

Conformity Assessment Certificate Conditions
Discusses entry and inspection powers, review requirements, fees and more.

Conformity Assessment Procedures
What is a CAP, examinations for all device classes, plus post-market monitoring systems.

Declaration of Comformity Overview
Covers purpose of the DOC, responsibility for conformity assessment and procedures.

Classification of Medical Devices
Discusses different classes of devices and rules for invasive and non-invasive devices.

Essential Principles for Medical Devices
Discusses medical device safety, intended purpose, minimization of risk and much more.

Essential Principles Checklist
Detailed checklist the directly correlates with the Essential Principles listed above.

Labeling Requirements, Medical Devices
General requirements for device labels, including sterile and non-sterile products.

Overseas Manufacturers, Standards For
How overseas manufacturers must demonstrate their goods meet acceptable standards.

Postmarket Activities
Discusses postmarket surveillance, compliance, adverse events, vigilance and more.

Regulatory System Overview
Overview of the new medical devices regulatory system.

Sponsor Reponsibilities
Role of the Sponsor/Manufacturer related to documentation, design, certification, etc.

Tamper Evident Packaging Codes
Requirements for wrappers, seals, packs, tubes, etc.. Covers validation and labeling.

TGA Fees
Complete schedule of fees as of 1 July 2004.

Canadian Medical Device Regulations (CMDR)

Canadian Medical Devices Regulations
Full text of the Canadian MDR as part of the Food and Drugs Act of 1998.

Transition to ISO 13485:2003
Brief document that discusses timeline for transitioning to ISO 13485:2003

ISO 13485 Audit Guidelines
Guidance document that discusses ISO 13485 QS audits performed by CMDCAS registrars.

Officially Recognized Registrars
Listing of registrars reconized by Health Canada and standards to which they may audit.

Health Canada Licensing Fees
Document detailing all medical device licensing and other fees for Canada.

European Medical Device Regulations

DIRECTIVES:

Active Implantable Medical Devices Directive (AIMDD)
Full text of European directive 90/385/EEC that governs active implantable medical devices.

In-Vitro Diagnostic Devices Directive (IVDD)
Full text of the European IVD directive 98/79/EC that governs in-vitro diagnostics.

Medical Device Directive, Full Text (MDD)
Full text of the European Medical Devices Directive 93/42/EEC.

Medical Device Directive, Proposed Changes (MDD)
December 2005 version of 93/42/EEC showing proposed changes.

Personal Protective Equipment Directive (PPE)
Full text of the European directive 89/686/EEC that governs personal protective equipment.

GUIDANCE DOCUMENTS:

MEDDEV 2.1/1 - Defines Medical Devices, Accessories and Manufacturer.

MEDDEV 2.2/1 REV 1 - Addresses EMC requirements.

MEDDEV 2.1/2.1 - Computers used to program implantable pulse generators

MEDDEV 2.1/2 REV 2 - Application of the Active Implantable Device Directive

MEDDEV 2.1/3 REV 2 - Demonstrates demarcation between the AIMDD and MDD.

MEDDEV 2.2/3 REV 3 - Discusses the "Use By" date.

MEDDEV 2.1/4 - Discusses demarcation between the EMC and PPE Directives.

MEDDEV 2.1/5 - Addresses medical devices with a measuring function.

MEDDEV 2.4/1 REV 8 PART 1 - Classification of medical devices. Part 1 of 2.

MEDDEV 2.4/1 REV 8 PART 2 - Classification of medical devices. Part 2 of 2.

MEDDEV 2.5/9 REV 1 - Medical devices containing natural rubber latex.

MEDDEV 2.5/3 REV 2 - When a quality-related inspection of a subcontractor is needed.

MEDDEV 2.5/5 REV 3 - Clarifies translation procedures.

MEDDEV 2.5/6 REV 1 - Defines homogeneity of production batches.

MEDDEV 2.5-7 REV 1 - Discusses conformity assessment for breast implants.

MEDDEV 2.5-8 REV 2 - Deals with assessment of devices with animal materials.

MEDDEV 2.7.1 - Talks about evaluation of medical device clinical data.

MEDDEV 2.10-2 REV 1 - Designation and monitoring of Notified Bodies

MEDDEV 2.11/1 REV 1 - Risk management in animal tissue products - TSE.

MEDDEV 2.12-1 REV 4 - Notification and evalution of adverse incidents.

MEDDEV 2.12-2 - Post market clinical follow up for medical devices.

MEDDEV 2.14/1 REV 1 - Borderline issues between the IVD and Medical Device Directives.

MEDDEV 2.14/2 REV 1 - Dealing with IVD products for research use only.

MEDDEV 2.15/2 REV 2 - Different committees or organizations related to medical devices.

Japanese Medical Device Regulations & Guidelines

Japanese Requirements Review - January 2005

US FDA Medical Device Regulations & Guidelines

Design Control Guidance for Medical Device Manufacturers
Text related to FDA 21 CFR 820.30 and subclause 4.4 of ISO 9001.

Food, Drug and Cosmetic Act
Section of Act as it relates to medical devices including Chapter 5, Subchapters A & E.

Labeling for Medical Devices
Guidance on medical device labeling from the FDA

Quality Systems Regulations (QSR)
US FDA QSR regulation and Good Manufacturing Practices (GMP).

Post Market Surveillance
Guidance on criteria and approaches for medical device post-market surveillance.

Human Factors in Medical Device Design
Discusses the CDRH push to have manufacturers apply Human Factors to device design.

RESEARCH:

Best Export Markets for Medical Devices
A 2003 study of medical device export potential. Source: U.S. Dept. of Commerce

Medical Technology Industry At A Glance
Details size of US and world medical device market. Source: AdvaMed, 2004

OTHER INFORMATION:

Glossary of Terms
Basic directory of medical device quality and regulatory terms, acronyms and definitions.

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