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Benefits of QMS

ISO Consulting

What is ISO?

Medical Devices & Labs

ISO 14000 Environmental MS
Expert Resource specializes in all of these standards. Our consultants provide comprehensive services including document development, training, implementation and consulting.



Medical Devices & Medical Laboratory Standards & Regs
(partial listing)

ISO 13485

CMDCAS (Canada)

ISO 14971

CMDR (Canada)

ISO 15189

FDA 510(k) (USA)

IVD

CE Mark (EU)

Clinical Trials PAL (Japan)
Technical Files TGA (Australia)
Software Validation  FDA GPM (QSR) 
 
Experienced Consultants for Medical Device and Laboratory Standards and Regulations


Medical Industry Compliance
ER helps medical device and medical laboratory companies implement ISO 13485, ISO 15189, ISO 14971, or GMP quality systems, obtain the CE Mark, submit FDA 510(k) applications, assist with clinical trails, and more. With offices and associates in the USA, Europe, Canada, Australia, Japan, and China, we can assist you with most international quality and regulatory compliance issues.

Funding: Many of our clients qualify for State and/or US Federal funding for training. This reimburses costs associated with consulting and registration. Please contact us for more information.


FDA 510(k) for USA Market

ER helps support medical device companies from around the world seeking approval to sell their products in the United States. One of the first steps for medical device companies who manufacture Class 2 devices (and a selected Class 1/3 devices) is to file a Pre-market Notification with the Food and Drug Administration, also known as an FDA 510(k) application. A Predicate Device -- that is a device similar to the one for which approval is being sought -- must already be approved and exist on the US market.

Our FDA 510(k) submission and preparation services include:

  • Verification that the predicate device(s) you wish to use in your submission meet the criteria.

  • Research and provide the required data from FDA Guidance Documents during our review process

  • Contact the FDA Office of Device Evaluation to determine any requirements for their review of this product

  • Assist in the preparation of the FDA 510 (k) submission

  • Submit the FDA 510(k) application (or amendment) to the FDA in a consistent manner for all submissions

  • Coordinate and work with the client and FDA review team. Often additional questions or more substantiated data are requested by the FDA

  • Assist with the preparation of a response if the FDA has questions or requires additional information

  • Act as the official correspondent on the application and remain accessible to the FDA for any future discussions regarding the 510k submission

  • Monitor the progress of the FDA 510(k) through the FDA review process and supply you with periodic updates as they become available

  • Prepare the Safety and Efficacy summary

  • Provide phone consultation during the FDA510(k) application and 510(k) approval process


CE Mark for European (EU) Market

In order to sell a medical device or IVD within Europe, a CE Mark must be on the product. The CE Mark is not a quality certification nor is it intended for consumers. It is used by the European Competent Authorities (National Ministries of Health) as a way to determine whether the product has met the requirements of the Medical Device Directive 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC or the Active Implantable Medical Device Directive 90/385/EEC.

The Medical Device Directive states that companies must:

  • Compile a Technical File with evidence of compliance to the Medical Device Directive (or the IVD/AIMD Directives)

  • Receive a CE Mark (CE Marking) certificate from a Notified Body if medium or high risk device

  • Appoint an Authorized Representative if no physical office in Europe

  • Register medical devices with the Competent Authorities
Once these requirements are met the CE Mark may be used.

Our CE Mark services include:
  • Technical file compilation & review

  • Verification of Requirements

  • Product classification & identification of applicable standards

  • Implementation & maintenance of ISO 13485 quality systems

  • Product labeling & packaging review

  • Risk assessment & management (ISO 14971)

  • Development of Vigilance Procedures & Post Market Surveillance

  • Authorized Representation for Europe


ISO 13485 and ISO 14971

ISO 13485 is the quality management system (QMS) standard specifically designed for Medical Device manufacturers. It includes 100% of ISO 9000 with extra requirements for medical devices.

ISO 14971 is the risk management system standard specifically designed for Medical Device manufacturers, often integrated into the design and development area of an ISO 13485 QMS.

If you currently have no quality management system in place, we will develop and implement an ISO 13485 and/or ISO 14971 system to get your company certified. Each system is customized for the manufacturer and may include compliance to any number of country regulations such as: European Union, Canada, USA, Australia, China, Japan, etc.

For more information on how we implement a phased approach to QMS development, see our ISO Management Systems section.


ISO 15189

This standard is the quality management system (QMS) standard for medical laboratories quality and competence. It is very specific to clinical laboratories and in vitro diagnostic test systems.

Typical ISO 9000 consultants won't do. If implementing ISO 15189, you'll certainly require the expertise of medical quality consultants such as Expert Resource. ISO 15189 is very robust and heavy with precise requirements.

For more information on how we implement a phased approach to QMS development, see our ISO Management Systems section.

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