FDA Concepts for Medical Device Companies

Putting a well-rounded and comprehensive Quality Management System

An efficient and effective Quality Management System (QMS) is a critical factor for the success of medical device companies. Having an effective QMS in place is absolutely necessary for medical device companies that have to satisfy the needs of all of their stakeholders. Further, an effective QMS is a means to ensuring that a medical device company’s products are safe and effective for its customers.

A medical device company has to show compliance with the necessary regulations. It should also enable the company to successfully demonstrate that compliance to the regulators. At the same time, this QMS system also needs to be efficient to allow medical device companies to meet the needs of their business stakeholders and shareholders.

Get the QMS right to show compliance

It is necessary for medical device companies to know how to put in place a QMS that meets all these varied and complex requirements. When medical device companies get trained on how to get their QMS right from all these perspectives, there is very little chance of going wrong.

To enable medical device companies get all the aspects of their QMS right; GlobalCompliancePanel, a highly renowned provider of professional trainings for the areas of regulatory compliance will be organizing a two-day seminar. To enroll for this highly interesting and useful learning session, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900651SEMINAR?FDA-concepts-medical-device-companies-San-Diego-CA.

Suzanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the Director of this seminar.

Concepts and characteristics of a good QMS.

Susanne will introduce participants to the Quality System Regulations and how they can be translated into a QMS that is both agile and rigorous when it comes to ensuring safe and effective products. She will give an understanding of the essential capabilities for managing an exceptional Quality System. 

Throughout the seminar, emphasis will be made on the regulatory expectations and how participants can translate these into their QMS.

The ways of structuring and optimizing their QMS will be among the core learning areas from this seminar. The starting point of all these is Management Responsibility and a commitment to quality. In discussing the concepts of management responsibility, a culture of quality, and continuous improvement; Susanne will make this learning comprehensive and well-rounded.

She will also explain the following at this seminar:

o   The tools and metrics needed for understanding the state of a QMS and ways of identifying and prioritizing opportunities for improvement

o   The four major Quality System elements that are emphasized by the FDA in their QSIT (Quality Systems Inspection Technique) inspections

o   Lessons learned from Recalls, 483s, and Warning Letters

o   Myths and challenges and how common problems can be avoided

o   Best practices that can be easily adopted.

Susanne will cover the following areas at this seminar:

o   Expectations for Medical Device Quality Management Systems

o   Regulations

o   Quality Management System Structure and Processes

o   Lessons Learned

o   Myths

o   Challenges

o   Best Practices

o   Inspection Readiness