Getting design controls right is absolutely essential for medical device companies

Design Controls are absolutely essential for ensuring the safe and effective production of medical devices. The FDA too considers design Controls a critical process. Yet, design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA. Although intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase; a significant percentage of all medical device recalls are due to design problems, as statistics show.

The implications of poor design of medical devices controls are quite obvious:

o   They account for a significant number of recalls

o   Design issues can result in complaints and medical device reports

o   Design issues can even create manufacturability issues such as low yields and excessive scrap and rework, for companies.

Get an understanding of the solutions and the ways of implementing them

So, the solution to this problem is to find and fix issues early on in the design process. This is a much more effective and inexpensive alternative to fixing problems for products already in production.

The ways of ensuring a trouble-free design control process will be taught at a seminar being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory compliance areas.

The Director at this seminar is Susanne 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. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900629SEMINAR to enroll for this seminar.

A valuable all-round learning session

Susanne will help participants understand and develop design controls processes and tools that are compliant with the regulatory requirements and are a competitive strength for their organizations. She will help them learn from past issues and improve their next generations of product.

She will help participants understand the requirements for design controls and how to translate them into an efficient and effective process for their organizations. She will start with the history and requirements for design controls. She will then move on to a discussion of the requirements and tools in detail. This seminar will include exercises to help participants practice and improve their design control process.

The following areas will be covered at this seminar:

o   Expectations

o   Regulations

o   Process

o   Lessons Learned

o   Myths

o   Challenges

o   Best Practices

o   Inspection Readiness.

Ways of conducting a hassle-free internal and supplier audit for medical devices

Carrying out efficient and effective internal and supplier audits that meet all the requirements of external auditors is a must for medical device manufacturers. These audits should not only serve this purpose; they should also add value to the medical device organization.

Part of both ISO 13485 and QMS

Internal audits are required as part of ISO 13485 and the FDA’s Quality System Regulation (QMS). However, these procedures are quite complicated for many professionals in the medical device industry.  They are often confusing and cumbersome, mainly because of the jargon and regulatory language they contain. Many organizations find it difficult to get the import of these words while wading through them all the way to a successful internal audit.

A tad complicated

Another couple of complicating factors come into play: Since the FDA does not look at the content of internal audits; many medical device organizations do not get feedback on the true effectiveness of their internal audit system from the FDA during the time of FDA inspections.

Secondly, while on the other hand ISO 13485 auditors do look at internal audits; they are most concerned with the process. For them, a proper definition of a process that meets the requirements of the standard and the assurance that the company is following these are more important than anything else. 

Auditor training is necessary

Both these regulations require that the medical device manufacturer define Auditor training. But there is a catch, because auditor training sometimes just requires reading the company's procedure, while most external auditors will look for more than this.

How does a medical device company extricate itself out of this quagmire? The solution to all these vexing questions will be offered at a two-day seminar from GlobalCompliancePanel, a globally known provider of regulatory compliance trainings.

At this seminar to enroll for which you need to just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900601SEMINAR; the Director, Betty Lane, who is Founder and President, Be Quality Associates, LLC, will explain all the issues relating to these aspects of external and internal supplier audits, in a way that is comprehensible and easy to implement.

In the process of explaining what makes for efficient and effective internal and supplier quality systems auditing for medical devices; she will also offer an explanation of best practices for creating and managing a value-added auditing process that will meet both company business needs and regulatory requirements.

At this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion; Betty will get participants to review all the quality management system requirements of FDA and ISO 13485 and then allow them to learn how to set up and manage an audit system that complies with these requirements, yet is risk-based so that their organization makes the most efficient use of auditing resources for both internal and supplier audits.

She will also include interactive exercises at this two-day session, which will help to strengthen the fundamentals of conducting and documenting quality system audits. The auditing principles taught in this seminar will be based on ISO 19011:2011 Guidelines for auditing management systems. 

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