FDA Quality System Regulations / Quality Management System (QMS)
FDA’s responsibility is to protect consumers and ensure that medical devices placed on the market are healthy and safe. FDA’s Title 21 Quality System Regulation Domestic or foreign manufacturers of medical devices are required by FDA to have “a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States. The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with GMP requirements in the QS regulation”.
Building a Quality Improvement Team: https://info.safelinkconsulting.com/blog/quality-improvement-team
SafeLink Consulting addresses your business needs whether they are simply to achieve FDA regulatory compliance or more in-depth analysis to improve your business.
How SafeLink Consulting can assist your business:
- FDA Quality System Regulations Title 21 Requirements
Either through our onsite visits or workshops, we will teach you how to ensure all required quality system elements are identified, scaled appropriately to meet compliance requirements, and effectively implemented. - Root Cause Analysis
SafeLink Consulting can help you improve your business by focusing on any components of your Quality management program to improve customer satisfaction and increase your bottom line. - Third-Party Audit for FDA or ISO FDA, & ISO all require that businesses conduct internal audits to show that compliance standards are being met.
- Quality System Internal Audit Audits are an independent and unbiased evaluation of your existing quality program. Audits will determine if a business complies with policies, contract commitments and regulatory standards. Contact SafeLink to schedule your business audit.
Companies intending to introduce certain classes of medical devices into the US market must submit a 510(k) to the FDA. After FDA’s clearance that medical device can be manufactured and distributed in the US. Changes in technology used to manufacture a device or a change in the intended use of the medical device can also require submission of a 510(k) premarket notification to FDA. SafeLink can assist you in determining your business needs.
Get assistance in determining if registration with FDA is required for your business activities as well as guidance through the FDA registration process.
- Due Diligence Consulting
Get a third-party evaluation of legal requirements regarding FDA, OSHA and other applicable state, federal and international requirements being met for a business you may be purchasing or selling.
Already have a quality system in place or considering implementing one and have some specific questions about your business? Contact us for quality guidance or assistance with an FDA inspection/response. Hourly consulting available.
Easily implement and manage your business’ quality manual and safety program online using the UQ System cloud-based application.
Enrich your FDA compliance knowledge and get continuing education credit with SafeLink Consulting’s online on-demand courses. These courses will help increase the effectiveness of your Quality Management System.
- Quality Connection
This subscription assists with your existing quality system, an FDA inspection/response if needed, or other quality issue. Includes consulting when needed, FDA assistance, online educational training courses, and quality news pertinent to your business.
Key Features of a Quality System
- Determines applicability and FDA registration
- Assigns management responsibility
- Defines purchasing controls
- Establishes traceability of patient contact materials
- Standardizes production and process controls
- Defines acceptance criteria of final product
- Reviews complaints and non-conforming product
- Creates Corrective and Prevention Action procedures
- Controls Labeling and Packaging
- Explains handling, storage, distribution and installation of materials and finished items
- Creates records retention and change controls
For more information on how SafeLink Consulting can help you develop your quality management program, contact us today.
SafeLink Consulting can help you:
- Save valuable time – we investigate the complicated FDA Quality System Regulations for you thus saving you hours spent from having to tediously research and understand it on your own
- Perform more efficient processes
- Strengthen communication skills with your customers and staff
- Respond to FDA if you receive an inspection
- Save you money – by contracting us at a fraction of the cost of hiring additional in-house staff to assist you with your quality assurance program
- Increase your productivity
- Minimize citations/fines in the event you are inspected by FDA
- Help you stay on track
SafeLink provides onsite consulting and follow up to help you comply with FDA requirements. For more information on our FDA consulting services, please contact us today for a quote.
