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ISO 13485:2003 and FDA regulated sevices

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The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.In the European Union, the fulfillment of EU Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.

The current European medical device quality system standard is EN ISO 13485:2003, which will replace current harmonized standards EN ISO 13485:2000 and EN ISO 13488:2000 with a three-year transition period ending July 2006. When manufacturers are active in the world market, the focus on global or international standards (e.g., ISO) is not only advantageous - it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485:2003.

Benefits of Medical Device Certification
Using QSG as your medical device certification partner brings numerous benefits:

ISO 13485 or in combination with regulatory certification, will be viewed by your customers, distributors and authorities as a genuine commitment to the quality of your medical devices during the approval or bidding process.
Most medical device manufacturers will eventually want to sell their products worldwide. The QSG will help you achieve this objective.
Regular assessments performed by QSG help you monitor and improve your management system and processes. This improves the reliability of your operations and products, ensures compliance with regulatory and customer requirements and increases financial performance.
ISO 13485 -- Who is certified to these standards?

Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union.

Companies, such as consulting shops, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, and medical component manufacturers.

Manufacturers of In Vitro Diagnostic Medical Devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.
ISO 13485:2003 Certification consulting:

We offer 3 options depending on the resources you wish to allocate for the implementation of ISO 13485:2003. All three options are SATISFACTION GUARANTEED.

1/ ISO 13485 Turnkey certification consulting:

If your company wishes to have QSG drive the implementation to comply and be certified with ISO 13485:2003, we offer an implementation service that follows a 5-step methodology: Gap assessment, quality management system upgrade, training, internal audit, and certification audit. We will provide and generate all the required documentation to meet the requirements of the standard. The implementation usually involves streamlining and simplification of your operation to take full advantage of the benefits of the standard. We have consultants in almost all the different states, Canada, Mexico, France, Brazil and North Africa.

We can secure for you Federal Funding or State Funding to cover the majority if not the totality of the cost associated with this program.

2/ ISO 13485 Desk audit:

If your company has internal resources (management representative, QA/RA Manager) and needs exacts guidance on what needs to be done, we offer desk audits that will help you comply with the standard you choose at minimal cost. We basically review all your operational documentation to identify any requirements not being met. You will need to send us a copy of your QA Manual or policies (Level 1), procedures (Level 2), and your organizational chart for a thorough audit/review on our part. The review will be under non-disclosure agreement and will maintain full confidentiality. We will then issue a detailed checklist of the modifications your system requires to comply with ISO 13485:2003. The checklist will be very specific to what needs to be done. We will also provide you with templates for the QA Manual (Level 1), a Continual Improvement Plan, and an Internal Audit Checklist that you can customize to meet the new requirements of the standard. Once the modifications are made, you will need to implement the changes in accordance with the recommendations in the report. The Upgrade Desk Audit is available in English, French, German and Spanish.

3/ ISO 13485 Online training and documentation templates:

If your company has internal resources (management representative, QA Manager/Supervisor) to conduct the implementation internally and does not want to spend any money on consultants, you will need to train your staff to ISO 13485:2003 and auditing to it. You will also need to provide them with documentation templates to conduct the upgrade. We offer very popular an effective online course that comes with the FREE higher-level documentation templates you will need. This course comes with a 15% discount if you register 10 or more trainees.

We guarantee your certification provided you follow our recommendation in a timely manner. The Online Training, the Desk Audit and the Turnkey Consulting are satisfaction guaranteed. If you are not satisfied with our work, you will get a full refund upon return of all the documentation generated or provided. The refund covers the latest billing period for onsite consulting.

Please contact us for more information.

About ISO 13485

The title of the ISO 13485 standards are as follows:

ISO 13485:2003
Medical Devices - Quality management systems - Requirements for regulatory purposes

EN ISO 13485:2003
Medial Devices - Quality management systems - Requirements for regulatory purposes adopted by the European Community as a European Norm (EN)

The ISO standards are copyrighted material and must be purchased from an approved vendor.

FDA and Internationally Regulated Medical Devices - Training Courses

- 510(k) Process for Medical Devices
- Auditor/Lead Auditor Training for ISO 13485
- CAPA Programs for the Medical Device Industry
- CE Marking, EU Directives, and Guidance Documents
- Design Control Concepts and Implementation
- Internal Auditor Training for ISO 13485
- Introduction to Process Validation
- Introduction to the Medical Device GMP
- Introduction to the Medical Device GMP: Executive Overview
- Process Validation Principles and Protocols
- Risk Management and Analysis for Medical Devices
- Software Verification and Validation Requirements
- Sterilization of Medical Devices
- Understanding ISO 13485 Quality Management System
- Using Lean six Sigma to Support FDA's PAT Initiative
- Understanding FDA's Medical Device Quality System Regulation

FDA Regulated Pharmaceuticals - Training Courses

- Risk Management and Analysis for Pharmaceuticals
- Understanding FDA's Current Grood Manufacturing Practice (CGMP) for Finished Pharmaceuticals
- Using Lean Six Sigma to Support FDA's PAT Initiative

For additional service for medical devices training and consulting services, please contact us.

Click here for a list of current training events

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