Our FDA compliance service line enables you to get your products to market quickly and to maintain your FDA compliance status. ISOplan  has helped  international 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.

FDA Regulatory Planning Clinical Trial Management 510(k)/PMA/DMF Submission FDA Quality System Services Quality System Project QSR/cGMP Audits Training Validation U.S. Agent (for non-U.S. companies)

FDA Regulatory Planning

• What are ISOplan’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 ISOplan 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

back

Clinical Investigation Management

• What are ISOplan’s Clinical Investigation 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 ISOplan 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.

back

 FDA Quality System Services

• What are ISOplan’s FDA Quality System 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 ISOplan 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.

back

 Quality System Project

•  What are ISOplan’s Quality System Project 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 ISOplan assist you?
  • ISOplan experts have been implementing Quality Systems since 1995, and has set up international 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.

back

 QSR/cGMP Audits

•  What are ISOplan’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 ISOplan assist you?
  •  we can provide you an audit that is the as what you can expect from the FDA.
  • We have audited international companies and helped them to go through a real FDA audit successfully.

back

 Training

•  What are ISOplan’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 ISOplan assist you?
  • We can put together customized training programs that are geared to your products and operations.
•  

Validation

• What are ISOplan’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. ISOplan'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 ISOplan 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)

U.S. Agent (for non U.S. companies)

• Non-U.S. medical device manufacturers must have a U.S. Agent that represents them in the U.S.  We can provide a qualified U.S. agent offering the following services: Establishment Registration, Device Listing updates, Medical Device Reporting, 510(k) Submissions and Official correspondent.

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.
  • ISOplan guides clients through the entire application preparation and submission process.
     
• How can ISOplan 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, ISOplan’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. 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 previous results, speak for themselves.

back