| 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 trials, 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 meets 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 510(k) 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 FDA 510(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.
|
