With a seemingly unlimited number of products coming under the broad umbrella of medical devices; it is but natural that regulations for these products are equally expansive. This makes medical devices compliance an extremely enormous and broad topic.
With the FDA being the sole regulator for this very vast area; it comes up with regulations, and expects medical device manufacturers to comply with them. This is part of the FDA’s primary function of assuring quality from medical devices. Compliance with these medical device regulations ensures that companies’ products meet the quality and safety and integrity of medical devices.
Areas of medical device compliance regulations
The FDA’s regulation of medical devices and a few nonmedical devices cover the areas of manufacturing, repackaging, and relabeling, and/or importing. The regulations for medical devices are set out in 21 CFR Part 807, whose various sections detail all the requirements for compliance for Class I, II and III medical devices. The following are the activities connected with compliance for medical devices:
- Registration of the establishment
- Listing of the medical device
- 510 (k)
- Premarket approval
- Investigational Device Exemption (IDE)
- Quality Systems
- Device labeling
- Device reporting.
A thorough understanding of the FDA medical device compliance areas
The ambit of the FDA’s regulations being very wide; it is important for medical device companies to have clarity on the many FDA medical device compliance regulations. This understanding will be offered at a seminar being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the areas of regulatory compliance.
The Director of this two-day seminar is Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc.
Please register for this webinar by visiting Understanding the infinite area of medical device compliance . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Helping to strategize compliance for medical devices
Medical device companies need to put in place a sound strategy for medical device compliance. A certain level of strategic thinking alone ensures this. Susanne will show participants how to inculcate this thinking and instill it into the organization. She will show how to be cost-effective while improving the quality and compliance of medical devices. The ways of building a sound Quality System, which is at the root of medical device compliance; will be imparted.
An effective and efficient Quality System can only be implemented based on a thorough understanding of what the regulatory requirements mean, and adapting them into the Quality System. The ways of doing this will be the core of this seminar. Susanne will demonstrate the ways by which to plan, structure and implement a Quality System that addresses the specific business needs of the participants.
Addressing issues within a Quality System
The methods for identifying, prioritizing and analyzing risks will be explained during the discussion on how to create a quality strategy and plans. Susanne will help participants explore the capabilities needed for every medical device to meet quality standards and implement compliant Quality Systems.
Also taken up for discussion are areas related to continuous improvement, Six Sigma, and Corrective and Preventive Action (CAPA), which are important components for addressing issues within a medical device company’s Quality System. Susanne will help with this very important aspect.
Over these two days, Susanne will also take up other crucial aspects of medical device compliance. These include:
- Effectively communicating and escalating risk
- Monitoring performance and progress
- Kick starting the Quality System to avoid common problems such as MDRs, recalls, 483s, and Warning Letters.
Susanne will cover the following areas at this seminar on medical device compliance:
- Quality System Expectations
- Quality System Structure
- Strategy and Planning
- Risk management in your quality system
- Case for Quality
- Inspection preparedness and management
- Monitoring and metrics
- Creating a quality strategy and plans.