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FDA Medical Device Regulatory Compliance for Medical Device Approval

FDA Medical Device Compliance for Regulatory Medical Device Approval

International Medical Device Requirements (MDR)

International Medical Device Requirements

mdi Consultants expertise in FDA medical device compliance enables your company to achieve, and maintain, your FDA medical device compliance standards; to make certain your medical device product reaches the market, not just quickly, but correctly. mdi Consultants also helps to maintain U.S. FDA medical device compliance status.

mdi’s experienced world-wide team of consultants is not limited to the United States, but covers European and Canadian laws, medical device regulatory requirements, standards, and directives to gain entrance into their markets.

mdi’s International and FDA services to Medical Device companies, has helped hundreds of Medical Device companies with our full array of Medical Device compliance and regulatory services, including:

  • 510(k)/PMA/DMF Submission Services;
  • Clinical Trial Management;
  • FDA Quality Systems and FDA Quality System Strategy;
  • QSR/cGMP Audits;
  • mdi’s FDA QSR/cGMP employee training and internal auditor training.

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Bring your products to market with FDA Compliance

mdi Consultants has a proven track record of helping hundreds of companies bring their product to market quickly and successfully, while maintaining FDA Compliance.

Below, is a list of our specific service offerings. Our job is to get your products to market quickly, under FDA compliant status.

Bring your products to market with FDA Compliance

mdi’s FDA Regulatory and Strategic Planning Services

Clinical Trial Management for Medical Devices

Mdi’s Clinical Trial Management services include developing you medical device’s 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.

510(k) Submission Services for Medical Device Companies

A 510(k) is a required application for medical devices that must be sent to the FDA in order to market a product in the U.S. after May 1976. Here is the procedure.

  1. Determine device classifications.

    • If applicable, submit a pre-sub to the FDA.

  2. Determine if there is an equivalent device and get comparisons.
  3. Determine what testing is required.
  4. Prepare the application.
  5. Pay FDA user fees.
  6. Submit the application.
  7. Assist with any FDA questions.

PMA Submission Services

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 medical devices where no substantially equivalent product currently exists.

DMF Submission Services

A DMF (Device master file) is a file submitted to the FDA,  which 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.

De Novo Submission Services

The de novo pathway for device marketing rights was added to address original medical devices of low to moderate risk not having a valid established device. Upon successful review of a de novo submission, the FDA creates a classification for the device, and a regulation if necessary, and then identify special controls required for future premarket submissions of significantly equivalent devices. Companies with novel devices of low to moderate risk have two options when considering the de novo pathway:

  • the company can submit a 510(k) to the FDA, and upon receipt of a “Not Substantially Equivalent” determination, the de novo request can be made; or,
  • the company can submit a de novo request without first submitting a 510(k).
  • Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

In addition: a company can submit a 513(g) petition for classification if there is no device classification; or, utilize a PreSub to the FDA, for FDA review. The FDA will respond, notifying the company that the device is a De Novo Candidate.

FDA Quality System Strategy

Assuring FDA compliance to quality system requirements for medical devices 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.

Quality System Implementation.

  • The 5 key elements to a quality system for medical devices are: quality manual, quality procedures, work instructions, product quality plans and production level quality records. mdi helps you to prepare and implement the entire system for FDA QSR (Quality System Regulation) /cGMP (Current Good Manufacturing Practices) compliance.
  • We supply you with a high-quality fully FDA compliant quality manual and procedures customized and implemented for your operation. Our solutions include management review, design control, corrective action/preventive action (CAPA) and complaint handling. The manuals and procedures are easy to read, follow and both electronically and paper-based.
  • Work instructions, product quality plans and production-level quality records are completely unique to each company, we work with you to ensure you are FDA compliant.

QSR/cGMP Audits for Medical Devices

  • 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 an 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.

Employee Training / Internal Auditor Training

mdi 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 inspection; and, how to prepare replies to FDA 483, and Warning Letters.

FDA Liaison

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.
mdi provides ongoing support allowing you to interact with our experts throughout the year. With this service, when an FDA event occurs, or a question arises, we are available to help you.
Dealing with the FDA inspections.
Responses to the 483.
Responses to the W/L.