 Quality System Compliance
Compliance with various standards/regulations is not only
mandated in some markets, but is often essential to doing business
domestically and internationally. We have the knowledge and experience to help
your company understand and meet these requirements. Whether it's compliance
with the varying quality system standards (ISO 9001, ISO 13485 or FDA's
QSR), compliance with the regulations governing the marketing and sale
of products (Europe's Medical Device Directive, Canada's Medical Devices Regulation, FDA's Pre-market Notification,
Registration and Listing, Labeling, etc.), or Medical Device Reporting
requirements, QA/RA Compliance Connection can assist you.
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Quality Management System Development
A quality management system is a type of management system
that just makes good business sense. It is premised on controlling and
continually improving
processes/systems; and ensuring quality products are
consistently produced which are safe and effective for their intended use and
meet or exceed the needs and expectations of customers. We can help you build
a quality management system that meets your needs. Whether it’s developing a
complete quality system or filling in the gaps, QA/RA Compliance Connection
can assist you with documentation development, revision, and streamlining.
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Quality System Assessment
Quality system assessments/audits provide critical data to
management for evaluating the adequacy and compliance of their organization's
quality system. They are a tool often used to determine a company’s
certification readiness. QA/RA Compliance Connection personnel are
RAB-certified Lead Assessors who have audited all types of organizations. We
will assess not only the adequacy of your system in meeting specified quality
system standards but also assess your compliance with the system implemented
to meet those standards.
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Gap Analysis
Gap analysis is a tool that can effectively be used to identify the gaps or
holes in a quality management system. Once these holes have been identified,
and the magnitude of the holes ascertained, a plan of action can be initiated
to correct them.
We will help you identify the missing elements in your system and work with
you to determine the best way to incorporate improvements.
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510K Compilation
Products meeting the definition of a device under Section 201(h) of the
Federal Food, Drug and Cosmetic Act (FD&C Act) are regulated by the FDA
(Food & Drug Administration). Medical devices are subject to general
controls and other controls in the FD&C Act. Unless specifically exempted,
medical devices must be properly labeled and packaged, be cleared for
marketing by the FDA, meet their labeling claims, and be manufactured under
Good Manufacturing
Practices, which is a mandated quality assurance system.
FDA regulates devices to assure their safety and effectiveness. In order to
market a medical device in the U.S., manufacturer's must go through one of two
evaluation processes: pre-market notification [510(k)], unless exempt, or
pre-market approval (PMA). Most medical devices are cleared for commercial
distribution in the U.S. by the 510(k) pre-market notification process.
A 510(k) is a marketing application submitted to the FDA at least 90 days
before marketing a medical device. The purpose of a 510(k) is to demonstrate
that the medical device to be marketed is as safe and effective or
substantially equivalent to a legally marketed device that was or is currently
on the U.S. market and that does not require pre-market approval.
QA/RA Compliance Connection can compile and submit your 510(k) to the FDA
in accordance with regulations.
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Technical File Compilation
All medical devices for sale into the European Union must conform to the requirements
of the Medical Device Directive (93/42/EEC), also known as the
"MDD". The MDD is basically a set of rules governing the sale of
medical devices into the European Community. The Directive requires medical
devices be safe when used for their intended purpose, and compliant with the
applicable "Essential Requirements" set out in Annex I of the MDD. A
product that satisfies Essential Requirements and whose manufacturer meets
appropriate conformity assessment requirements is entitled to bear the
CE mark and may be placed on the European Market.
To demonstrate conformity of a product with the requirements of the
Directive, manufacturers are required to maintain a technical file (also known
as a "product dossier") for
each product for which they intend to CE mark. The technical file must be kept
available for review by any Competent Authority or Notified Body.
The technical file is a collection of technical documentation, similar to
the FDA 510(k), to demonstrate product conformity with the Essential
Requirements of the Directive and the product-specific requirements of the
applicable conformity assessment annex.
We can assemble your technical file in accordance with the Medical Device
Directive requirements.
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Facility Registration
Unless exempt under Section 510(g) of the FD&C Act, the owner or
operator of an establishment must register their organization(s) with the FDA
within 30 days after beginning any of the following activities: manufacturing,
propagation, compounding, assembly, or processing of a device intended for
human use. Activities requiring registration include re-packaging,
re-labeling, distributing of imported devices, and specifications development.
We can complete and submit your device establishment registration in
accordance with FDA regulations.
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Device Listings
All manufacturers are required to list the generic type of devices they
have in U.S. commerce with the FDA. Submission of this information should be prior to commercial distribution.
QA/RA Compliance Connection can complete and submit your device listings in
accordance with FDA regulations.
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Official Correspondent
An Official Correspondent is a person designated by the owner or operator
of an establishment as responsible for the following: (1) The annual
registration of the establishment; (2) Contact with the Food and Drug
Administration for device listing; (3) Maintenance and submission of a current
list of officers and directors to the FDA upon the request of the
Commissioner; and (4) The receipt of pertinent correspondence from the FDA
directed to and involving the owner or operator and/or any of the firm's
establishments.
QA/RA Compliance Connection can assume the role of Official Correspondent
for your organization.
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Complaint Handling & Medical Device Reporting
21 CFR Part 820.198 requires that manufacturers establish and maintain
procedures for processing complaints. It further requires that manufacturers
maintain complaint files. A complaint is defined as any written, electronic,
or oral communication that alleges deficiencies related to the
identity, quality, durability, reliability, safety, effectiveness, or
performance of a device after it is released for distribution. Additionally,
the FDA Medical Device Regulations have required firms who
have received complaints of device malfunctions, serious injuries or deaths
associated with medical devices to notify the Food and Drug Administration of
the incident. The MDR regulation provides a mechanism for FDA and
manufacturers to identify and monitor significant adverse events involving
medical devices.
QARA Compliance Connection can assist your organization with the
development of systems or procedures for handling complaints and adverse
events and ensure the appropriate information is being recorded and
maintained. We can also assist with the various reporting requirements imposed
by the regulations.
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Recall & Remedial and Correction Activities
A recall is a correction or removal of a marketed
product that the Food and Drug Administration (FDA) considers to be in
violation of the laws it administers and against which the agency would
initiate legal action, e.g., seizure. (A market withdrawal or stock recovery
is not included in this definition).
Recall is a voluntary action and may be undertaken at any time by
manufacturers, or at the request of the FDA. Manufacturers recall products in
order to protect the public health and well-being from products that present a
risk of injury or gross deception or are otherwise defective.
Firms are required to notify the FDA immediately of product recall.
Medical Device Correction and Removal requires manufacturers to make a report to the FDA of any correction or
removal of a device initiated by such manufacturer if the correction or
removal was initiated: to reduce a "risk to health" posed by the
devices; or to remedy a violation of the act caused by the device which may
present a risk to health unless the information has already been provided by
medical device reporting requirements or the correction or removal action is
exempt from reporting requirements. The report must be submitted to the
appropriate FDA district office within 10 working days from the time the firm
initiates the recall. If there is not a "risk to health" involved, a
report to FDA is not required, but the manufacturer must keep a record of the
correction or removal.
QARA Compliance Connection can assist your organization with FDA reporting
requirements and help you ensure your records contain the appropriate
information. We can also help you to develop a recall strategy, for
firm-initiated recalls, as well as assist you with recall communication
activities and status reports.
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Certificates for Foreign Government & Certificates of Exportability
The export provisions of the FFDCA do not apply to firms who wish to export
devices that are legally marketed in the U.S. Any medical device legally on
the U.S. market may be exported anywhere in the world without prior FDA
notification or approval. While FDA does not place any restrictions on the
export of these devices, certain countries may require written certification
that a firm or its devices are in compliance with U.S. law. In such instances
FDA will accommodate U.S. firms by providing a Certificate for Foreign
Government (CFG).
For those firms who wish to export a device that is not legally marketed in
the U.S. but which meets the requirements of section 801(e)(1); could
reasonable obtain a 510(k) clearance or would be exempt from the 510(k)
requirements; and where the foreign country has requested written assurance
that the product complies with U.S. law, the FDA will accommodate U.S. firms
by providing a Certificate of Exportability.
QARA Compliance Connection can assist your organization to obtain
Certificates for Foreign Government and Certificates of Exportability.
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OTC Drug Products and Cosmetics
QARA Compliance Connection can assist you with identifying cosmetic and OTC drug product
testing and labeling requirements as well as complete and submit drug
establishment registration and drug listings in accordance with regulations.
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Training
QARACC offers both on-site instructor training and CD-ROM
training modules to meet your individual training needs. Seminars are also
offered. See our On-Site Instructor Training, Training Seminars, or
Training Products page for more information.
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Supplier Audits
Need to audit your supplier's or contractor's quality
system to ensure and verify compliance with FDA or company requirements but
don't have the time and/or expertise to do so? Call QARACC today @ (813)
784-8457 or email info@qaracc.com.
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