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.

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

  • They account for a significant number of recalls
  • Design issues can result in complaints and medical device reports
  • 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.

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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:

  • Expectations
  • Regulations
  • Process
  • Lessons Learned
  • Myths
  • Challenges
  • Best Practices
  • 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.

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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.

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:

  • Managing risks
  • Validation of processes
  • Establishing product/process specifications to QC to such specifications
  • Monitoring compliance to such specifications

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Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in their products, leading to lowered customer satisfaction levels, severely impacting their bottom line.

A learning session to help understand statistical methods

In order to help professionals in process and manufacturing meet challenges associated with statistical methods with greater confidence, GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance areas, is organizing a highly educative two-day seminar on the topic, “Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC”.

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John N. Zorich, Statistical Consultant & Trainer, Ohlone College & SV Polytechnic, will be the Director 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.

To enroll for this seminar, participants can log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900537SEMINAR.

Hands on approach to statistical methods toolbox

The aim of this seminar is to offer a hands-on approach by which the participants could comprehend the ways to interpret and use a standard tool-box of statistical methods that consist of confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

The Director will equip the seminar delegates with clarity on how to accurately employ and administer statistical methods, which can be used as a launchpad for introducing new products.

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This two-day session will help participants understand the proper way of avoiding issues relating to these aspects of statistical methods. John will explain how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing by giving real life examples derived mainly from the medical device design/manufacturing industry.

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John will cover the following areas at this seminar:

  • FDA, ISO 9001/13485, and MDD requirements related to statistical methods
  • How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
  • Design Control processes (verification, validation, risk management, design input)
  • QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
  • Manufacturing processes (process validation, equipment qualification).

Tools and Methodologies to Predict and Improve Product Reliability

Improving product reliability may be the primary objective of reliability analysis; yet, there are many possible reasons for collecting and analyzing reliability data. There are many examples of collecting and analyzing reliability data. This could be done to assess product reliability in the field. It could be to predict product warranty costs. It could be for estimating replacement part/spares requirements.

Other examples of collecting and analyzing reliability data include:

  • To assess the effect of a proposed design change
  • To demonstrate product reliability to customers or government agencies
  • To compare components from multiple suppliers
  • To compare components from different production periods, operating environments, or materials
  • For improving reliability through the use of laboratory experiments.

Methodologies for doing these

There is a certain overall methodology for setting reliability targets, estimating product reliability from test data and/or field data, and determining whether or not reliability targets are achieved. The intricacies of this methodology will be the content of a two-day, in person live seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas.

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Steve Wachs, who is currently a Principal Statistician at Integral Concepts, Inc., brings over 25 years of wide-ranging industry experience in both technical and management positions. To derive the benefit of hearing this experienced professional, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900409SEMINAR to register. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Calculating sample sizes

Steve will discuss the methods for estimating the reliability of subsystems and systems. He will also show how to calculate sample sizes for reliability testing and utilize reliability models to develop forecasts of future failures (e.g. warranty forecasts).

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This course will immensely benefit anyone with an interest in product quality and reliability, such as Product Engineers, Reliability Engineers, Design Engineers, Quality Engineers, Quality Assurance Managers, Project/Program Managers, or Manufacturing Personnel.

Steve will help participants with the following:

  • Understand reliability concepts and unique aspects of reliability data
  • Understand underlying probability and statistical concepts for reliability analysis
  • Develop competency in the modeling and analysis of time-to-failure data
  • Understand reliability metrics and how to estimate and report them
  • Estimate reliability of subsystems and systems
  • Determine if reliability specifications are met (at specified confidence level) or whether design improvements are required
  • Develop competency in the planning of reliability tests (excluding ALT)
  • Analyze existing warranty data to predict future returns
  • Develop awareness of more advanced topics in Reliability

Application of concepts and theories of clinical research

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual’s private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed.

There are also state statutes, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research. This is done to ensure that the research not only meets the regulatory requirements but also that it is conducted in an ethical manner, coming with adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research.

Guidelines lack clarity

However, the challenge that this position presents is that the guidelines –which also provide interpretation of the regulations –are not always as clear as they might appear upon first reading them.

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will impart understanding on all these grey areas of human subjects. It will clarify on these regulations. To enroll for this highly educative session, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900671SEMINAR.

The Director of this seminar is the highly regarded expert on the subject, Sarah Fowler-Dixon, Education Specialist and instructor with Washington University School of Medicine. Sarah has developed a comprehensive education program for human subject research which has served as a model for other institutions.

Ways of applying concepts and theories

This two-day seminar will provide the foundation for the application, concepts and theories of clinical research.

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The speaker will not only provide a refresher of the regulations; she will also provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment, an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participant signing an outdated consent document, etc.) when conducting human subjects.

Outcomes of the seminar

The learning acquired over these two days will help attendees learn about the historical evolution of research, and current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. This session will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. It will also discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.