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.

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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.

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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.

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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.

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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.

Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

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There are three types of Premarket Notification 510(K)’s that may be submitted to FDA: Traditional, Special, and Abbreviated. Product modifications that could significantly affect safety and effectiveness are subject to 510(K) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance with 21 CFR 820.30 Design Controls. The FDA provides guidance on these.

Needed: A thorough understanding of these aspects and the FDA’s latest proposed changes

In accordance with the concern evinced by many industry groups and associations, the FDA introduced as many as 60 proposals in August 2010, into the manner in which the 510 (K) process could be expedited. This was done with the intention of accelerating the speed at which newly approved medical devices could be made available to patients across the country. However, with the number of proposals being too many and their scope being too wide; the medical industry suggested that the FDA select for implementation only those proposals that enjoyed the broad consensus of the stakeholders, such as increased reviewer training, development of specific and relevant guidance documents, and enhancements or improvements to the de novo review pathway, among other suggestions.

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An upcoming seminar by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance industries, will clarify on these areas taken up for immediate change by the FDA and place them in the right context. It will address key resources when making critical decisions. This seminar will offer important insights into the core areas of premarket notifications, as well as the Design Control requirements under QS regulations and Design Controls.

To enroll for this seminar, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900527SEMINAR.

The Director at this seminar is David R. Dills, a senior Regulatory Affairs & Compliance Consultant. David provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.

An understanding of the core elements of the PMA

At this seminar, David will help participants understand how medical device manufacturers can locate a “predicate” device and go through the content and format of the 510(K), and offer an understanding of the De Novo process and the expectations for possibly marketing a low risk device, and the potential impact of FDA’s proposed changes to the 510(K) process and why manufacturers need to pay attention to these.

He will also offer understanding of all the crucial aspects of the PMA, such as the differences between the Traditional, Special and Abbreviated submissions, an understanding of the Substantial Equivalence and how it is applied, who is required to submit the application to FDA, where to submit the 510(K) and what to expect with the review and approval process, when a device company requires this process and when it does not, the applicable exemptions to the submission process and special considerations, and so on.

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:

  1. Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;
  2. Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.

Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.

Risk Management Shows Identifying, Evaluating And Treating Risks

Learn the ways of doing it right from start till finish

The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas will impart.

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Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900683SEMINAR.

In line with globally applicable standard requirements

International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.

Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.

Understanding safety assurance cases

The ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place to comprehensively summarize all risk related activities and to demonstrate the safe properties of a device. Currently only required for FDA infusion pump submissions; this documentation will most likely become mandatory for all devices. This course will introduce the basic concepts and content of safety assurance cases and will illustrate their usefulness for internal and external review of safety related information.

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This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden.