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FDA Compliance for
Medical Devices Companies
Our FDA compliance service line enables you to get your products to market
quickly and to maintain your FDA compliance status. mdi has helped
hundreds of companies to achieve and maintain their FDA compliance. Below,
you will see a list of our specific service offerings. Please click on an
item below for more information.
PRODUCT
LIFECYCLE
FDA Regulatory Strategic Planning
- What are mdi’s FDA Regulatory Strategic
Planning Services?
- Given that we understand the product development
process, the FDA submission process and the interplay between these
processes, we can craft a regulatory strategy based on your situation.
This strategy will include thinking through what actions you take,
what you document, what submission process to take, how to structure
your clinical trial, etc.
- How can mdi assist you?
- Many clients underestimate the economic value of a
carefully thought out FDA regulatory strategy. Because of our
experience and understanding of the FDA, through careful planning we
can help you to:
1. Minimize the time it takes to get through the
submission process, by correctly laying out the steps required and
preparing your submission appropriately
2. Minimize the cost spent in the submission
process by defining a specific roadmap that allows you to identify
the correct type of submission, eliminate the typical clinical trial
management mistakes and reduce quality system implementation errors
3. Maximize your product revenues by enabling you
to sell your product while the FDA reviews your files
4. Optimize your competitive situation by thinking
through how your submission type and structure will effect your
competitors, suppliers and customers
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Clinical Trial Management
- What are mdi’s Clinical Trial Management Services?
- Our services include developing the
clinical protocol, setting up and interacting with the IRB
(Institutional Review Board), submitting the IDE (Investigational
Device Exception), recruiting and working with the investigator,
monitoring the trials, data gathering and analysis, project
management, and statistical analysis.
- How can mdi assist you?
- We work closely with the product's sponsor in
managing the clinical trials required for market approval. The study's
protocol would be based on the necessary requirements for obtaining
FDA's approval in the quickest and least expensive manner.
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510(k)/PMA/DMF Submission
- What are mdi’s 510(k)/PMA/DMF Submission Services?
- A 510(k) is a required application that must be
sent to the FDA in order to market a product in the U.S. A 510(k) must
be submitted for certain Class I devices as well as for Class II and
certain Class III devices. It must be submitted for products that have
been marketed after May, 1976 (when the regulations took effect) and
for products where a substantially equivalent (SE) product can be
found in the market.
- A PMA (Premarket Approval) is a required
application that must be sent to the FDA in order to market a product
in the U.S. A PMA is required for certain Class II and Class III
devices where no substantially equivalent product currently exists.
- A DMF (Device master file) is a file that is
submitted to the FDA that includes technical, clinical, and safety
information about a medical device component or material. If you are a
component maker, your customers may desire a DMF from you.
- mdi guides clients through the entire application
preparation and submission process.
- How can mdi assist you?
- Correctly submitting any of these documents to the
FDA is both science and art. Unless you have extensive experience in
this field, you may encounter some difficulties that you did not
anticipate. For 510(k)s we have observed many of the following
problems
- Cover letters that are unclear, poorly written,
highly technical, contradict application and/or include unsubstantiated
claims
- Incorrect classification of a device (e.g. PMA
submission that should have been a 510(k)
- Incorrect comparisons of device vs. predicate
devices
- Poor presentation of clinical trial data
- Little understanding of the clinical trial
requirements
- Limitations and counter indications that
undermine product safety or efficacy
- Advertising material that doesn’t match
intended use
- Underestimation of the amount of communication
and relationship-building that needs to be done with the FDA reviewer
- If you supply us with the following information
concerning your device, mdi’s specialists can provide you the best way
to approach the FDA – either 510(k) or PMA, your estimated time for
FDA review, and an estimate of the testing and submission costs:
- Intended use of your device
- What legally sold device that you are claiming
that your device is substantially equivalent to
- The risks and hazards associated with the use
of your device
- The materials your device is made with
- Our staff has in-depth knowledge on how to submit
these applications and has developed strong relationships with the FDA
over the last 25 years. Given our experience, we can work with you to
successfully achieve approval for your submission whether you want us
to do it completely or for us to simply guide you through the process.
Our results of over 500 successful approvals, speak for themselves.
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FDA Quality System Strategy
- What are mdi’s FDA Quality System Strategy Services?
- Assuring FDA compliance to quality system
requirements is critical for all medical companies. The quality system
requirements are defined by QSR (Quality System Regulations) /cGMP
(Current Good Manufacturing Practices) guidelines which are specified
by the FDA.
- The process by which to achieve compliance to these
requirements is different for each company. For example, large companies
may need to prioritize geographically-different operations based on
size/importance and implement systems accordingly. A smaller company may
need to prioritize which elements of the quality system to implement
first (e.g. work instructions, design control) in order to get in
compliance quickly.
- How can mdi assist you?
- Making these types of decisions requires thought
and planning because these decisions will affect the speed and cost of
the total implementation, potential savings that could be realized
through a quality system implementation and the level of comfort the
FDA will have that you are implementing a compliant quality system.
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Quality System Implementation
- What are mdi’s Quality System Implementation
Services?
- There are 5 key elements to a quality system:
quality manual, quality procedures, work instructions, product quality
plans and production level quality records. We can help you prepare
and implement the entire system for FDA QSR (Quality System
Regulation) /cGMP (Current Good Manufacturing Practices) compliance.
- We can supply you with a high-quality fully FDA
compliant quality manual and procedures that can be customized and
implemented for your operation. Our solutions include everything from
management review, design control, corrective action/preventive action
(CAPA) and complaint handling. The manuals and procedures are easy to
read, follow and implement with the necessary procedures and forms. We
can implement them both electronically and paper-based.
- Since work instructions, product quality plans and
production-level quality records are completely unique to each
company, we can work with you to ensure that you are FDA compliant.
- How can mdi assist you?
- mdi has been implementing Quality Systems since
1978, and has set up over 350 companies worldwide. We can guarantee
that the quality system will meet with all the FDA requirements. The
systems have been continuously inspected by the FDA and have passed
each and every audit for compliance to the QSR/cGMPs.
- If you are
looking to sell product to the European Community, we can also ensure
that the systems we implement will meet the ISO 9001:2000 or ISO 13485
standards as well.
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QSR/cGMP Audits
- What are mdi’s QSR/cGMP Audit Services?
- We can perform a mock FDA audit of your operations
to determine compliance to the FDA QSR (Quality System Regulation) /cGMP
(Current Good Manufacturing Practices).
- The audit would be performed in similar manner to a
FDA audit and will be performed by former US FDA field investigators.
- These mock audits serve two purposes: testing your
quality system and providing recommendations for corrective actions.
- How can mdi assist you?
- Given that we have been officially recognized as
experts by the FDA, we can provide you an audit that is the same as
what you can expect from the FDA.
- We have audited hundreds of the companies and
helped them to go through a real FDA audit successfully.
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Training
- What are mdi’s Training Services?
- We provide FDA QSR/cGMP employee training and
internal auditor training.
- Our in-house training sessions include all aspects
of FDA regulatory and quality system requirements including: cGMP
compliance, Design Review, Process Validation, Sterilization
Validation, FDA strategic Planning, Dealing with FDA inspections and
how to prepare replies to FDA 483 and Warning Letters.
- How can mdi assist you?
- We can put together customized training programs
that are geared to your products and operations.
- We have trained thousands of employees over the
last 25 years.
Validation
- What are mdi’s Validation Services?
- There are three types of validation
- Process Validation - We can assist in the
preparation of the validation protocol, implementing the validation
and interpreting the data to meet with the FDA guidelines.
- Sterilization Validation - For contract
sterilization, we can review installation qualification
documentation from the vendor. For new sterilizers, we can perform
installation, qualification of equipment, testing, calibration and
documentation. We can prepare protocol for performance qualification
and validate the process by testing as per the protocol. We will
then certify the process with documentation accumulation, review and
approval.
- Software Validation - Our software validation
assistance includes: validation protocol preparation; hazard
analysis; FMEA; and review. mdi's staff will work closely with your
staff to evaluate your validation requirements and present a full
program and milestone chart for ensuring your software validation is
completed within a scheduled timeframe.
- How can mdi assist you?
- We can put together complete validation protocols
as well as execute the validations for you. Contact us for more
information on our validation services.
- Our services comply with the FDA’s Analytical
Method Validation (AMV) (including, linear regression analysis,
precision, accuracy, limit of detection, limit of quantification,
specificity and stability indicating determinations) and Analytical
Instrumentation Installation and Operational Qualifications (IQ/OQ's)
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FDA Liaison
- What are mdi’s FDA Liaison Services?
- An FDA inspection could be one of the most trying
times in dealing with the FDA. Knowing what to expect, trying to
interpret the FDA findings and providing immediate solutions to
prevent regulatory actions could be critical to the survival of a
company.
- We provide ongoing support that allows you to
interact with our experts throughout the year. With this service, when
a FDA event occurs or a question arises, we are available to help you.
- How can mdi assist you?
- mdi's staff has successfully navigated numerous
companies through FDA inspections both domestically and
internationally where the consequences of an actionable inspection
could prevent product commercialization.
- Our staff of former US FDA field investigators,
with over 100 years of combined FDA regulatory experience, provides a
professional demeanor to the FDA visit and assists to expedite the
inspection in a manner that has been proven over time.
- Our regulatory experience in dealing with the FDA
is unsurpassed, with successful removals of injunctions, seizures and
warning letters. Please see what our clients have had to say about our
services during an audit.
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U.S. Agent (for non-U.S. companies)
- What are mdi’s U.S. Agent Services?
- Non-U.S. medical device manufacturers must have a
U.S. Agent that represents them in the U.S.
- Our U.S. agent offering provides the following
services: Establishment Registration, Device Listing updates, Medical
Device Reporting, 510(k) Submissions and Official correspondent.
- How can mdi assist you?
- mdi is a U.S. Agent for foreign medical device
manufacturers in accordance with the US FDA regulations.
- For more information on this offering, please visit
our special website at
www.fdadesignatedagent.com
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