Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

Learn how to design regulatory strategy for your medical device to expand your business in Brazil & Argentina. Get insight in to regulatory policy and implication for medical device and the key issues in medical device laws of Brazil and Argentina.

This webinar will teach you the key elements on how to build a winning MDR team and its process. This webinar will discuss the best practices in complaint handling, screening & evaluation for reportability, employee training and expectations which helps the medical device manufacturers in building an effective MDR Reporting and stay abreast of regulatory changes and lead key personnel to stay current in training and compliance.

This medical device reimbursement webinar will discuss the similarities and differences in reimbursements between US and abroad. It will teach how to develop the domestic and international strategies for effective reimbursement.

In this session Mr. Shapiro will provide an overview of the history of the ISO13485, and the newly introduced changes. The Speaker will also discuss how the changes interact with regulatory requirements, and how to face the new changes. The webinar will focus on key provisions and considerations when establishing a QMS as per the ISO13485: 2016, and identify pitfalls that should be avoided.

This webinar will provide valuable insight to design assurance and quality assurance engineers looking to simplify or condense design development activities into one document for easier traceability. This webinar is also ideal for startup companies who are unfamiliar with FDA design development regulations and are looking for a place to start in their path towards compliance.

This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.

This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.

This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.

This webinar examines the issues in audit sampling and provides the answers one need to plan audit. It will help attendees understand the use of standard sampling plans in an audit including FDA’s QSIT sampling plans.

This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations.

This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data.

This webinar will explain how to create, develop and manage Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods.

This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.

This webinar on selling medical devices in the European Union (EU) will immensely benefit companies wishing to penetrate the EU market for medical devices or sharpen their skills. It will provide practical guidance on achieving the CE mark. Medical devices sold into the European Union (EU) must comply with the applicable medical device directives and EU laws similar to FDA’s regulations.

This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.

This webinar will discuss the fundamental statistical concepts to perform an effective process validation. Attendees will learn best practices to comply with QSR and ISO 13485:2016 requirements for process validation.

This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.