Streamlining FDA Compliance: Making the Move from Manual Processes to Mouse Clicks
The time and money required for complying with FDA regulations is stifling for most medical device manufacturers. A recent company cited over a 6 week delay in sending a 510K submission to the FDA, not to mention the errors and exceptions of a manual process and cost of brining on additional staff to assist in the effort. Many companies are searching for an engineering platform to automate this critical, yet costly area. Chris McHale from SPK Associates, an expert in engineering processes including FDA specific compliance, will walk through the specific challenges facing most medical device companies. In addition, she will clearly outline a solution framework for automating FDA compliance, significantly reducing the time and costs associated. Matt Klassen from MKS will then discuss how MKS has solved these challenges effectively for many companies and demonstrate the MKS solution built on MKS Integrity, a leading ALM engineering platform.
Christine McHale, VP of Operations, SPK and Associates
Christine McHale is the VP of Operations for SPK and Associates, LLC. In this role, Ms. McHale is responsible for directing SPK’s Engineering Technology consulting practice as well as the IT Infrastructure Services practice. With over 18 years experience in both implementing and selling services addressing the unique needs of Engineering or Product Development organizations, Ms. McHale brings a depth of practical knowledge and experience to the role.
Chris spent many years delivering services to R&D groups to implement and support a variety of Mechanical CAD, EE and Software Engineering solutions. As such, she has a deep knowledge of Engineering requirements, processes, and applications. She has designed and deployed many Application Lifecycle Management (ALM) solutions, in particular to companies developing product with both hardware and software components. She is well versed in the compliance requirements faced by regulated companies, and has integrated processes and tools in these solutions that minimize effort and time required from Engineering.
Matt Klassen, Solutions Manager, MKS Inc.
Matt Klassen is the Strategic Solutions Manager for MKS Inc. In this role, Mr. Klassen is responsible for leading the effort to craft software and systems lifecycle management (ALM+) solutions built on MKS Integrity, the company’s flagship engineering platform. With over 12 years experience in consulting, implementing, training, selling, and marketing Agile, iterative and waterfall based software and systems engineering solutions across industries, including aerospace, healthcare, financial, medical devices, electronics, automotive, and telecom, he brings a wealth of knowledge and a history of success to the role.
Starting his career as a software engineer and architect gives Matt a great foundation for understanding the technical, process, and organizational challenges facing software and systems groups today. Matt spent a significant amount of his career with Rational and Borland (pioneers in software, systems, and application lifecycle management) where he served in customer facing roles in many regulated industries including Medical Devices, Aerospace & Defense, and Healthcare. He has a passion for understanding the specific industry and customer challenges in depth such that the right solution is implemented and validated against specific business objectives.
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