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.
- 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.
- 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.
- 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.
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 we 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)
RISK ANALYSIS
- Risk analysis is required for medical devices by most of the world regulatory authorities. The application of risk analysis spans the entire life cycle of the device, starting from the design and development phase to post-marketing design changes.
- Risk analysis is being increasingly called out by the regulators for integration into the entire quality system. Examples of this include applying risk analysis during complaint investigations and Corrective and Preventive Action (CAPA) implementations.