David R Dills
Regulatory Affairs & Compliance Consultant
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
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Recorded Webinar
Labeling, Advertising and Promotion in a Regulated Environment
The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced communication technology that can go "viral" and just as quickly disappear is the question that the industry is eager to have answered.
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Technical File Structure according to New EU Medical Device Regulation
This course describes the structure and content of a technical file and its main attachments for the CE marking of a medical device.
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Requirements for Registration of Medical Device Products in China
China's medical device market is rapidly growing these years, China offers numerous opportunities for foreign healthcare related companies but understanding the practicalities of accessing the market is not simple. Attend this training, if you are a manufacturer or distributor involved in exporting medical devices or IVDs to China, this webinar will provide you with necessary briefing on CFDA registration of medical devices.
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MEDDEV 2.7.1, Revision 4 for Clinical Evaluation and the Latest 2016 Guideline: A Guide for Manufacturers and Notified Bodies
This webinar will explore the key changes, discussing the new requirements and noting the main clarifications within the guidance document. It will highlight the areas for you to be aware of and consider when conducting clinical evaluations.
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FDA Regulation of Digital Health - Current Status and Recent Developments
Why is the FDA focusing on Digital Health? Many medical devices now have the ability to connect to and communicate with other devices or systems. Devices that are already FDA approved or cleared are being updated to add digital features. New types of devices that already have these capabilities are being explored. Many stakeholders are involved in digital health activities, including patients, health care practitioners, researchers, traditional medical device industry firms, and firms new to FDA regulatory requirements, such as mobile application developers. The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Health information technology (HIT) presents tremendous benefits to the public, including greater prevention of medical errors, improved efficiency and health care quality, reduced costs, and increased consumer engagement. However, if HIT is not designed, developed, implemented, maintained, or used properly, it can pose risks to patients.
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GMPs for OTC and Cosmetic Products - US and Global Requirements
This webinar will help the attendees learn the FDA requirements for OTC products related to drug establishment registration, drug product listing and adherence to GMP regulations. The speaker will also provide an overview of Current Good Manufacturing Practices for personal care, cosmetic and OTC products and how the Quality Systems approach can support regulatory compliance not only in the United States but also the European Union and elsewhere. The cosmetic good manufacturing practice is a set of manufacturing guidelines to ensure the safety and quality of cosmetic products. OTC drug manufacturers, labelers, packagers and holders must comply with good manufacturing practices.
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Medical Device Registration and Approval Process for South America
Learn how to register your medical devices and gain approval from the regulatory authorities in Brazil, Argentina and Columbia.
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Preparing and Submitting a Well-Written 510(k): Latest FDA Changes to the Process
This webinar provides an overview of the premarket notification process and all of the critical and key steps required to ensure you prepare and submit a well-constructed 510(k). Provides and overview of the 510(k) Program including the basics of how to prepare and submit a 510(k) to the FDA and recent changes and trends.
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Medical Device Registration and Approval Process for the Pacific Rim (including China, Singapore, Taiwan and Hong Kong)
This webinar provides an overview of registration and approval process for medical devices and IVD's in China, Singapore, Taiwan and Hong Kong. To see their products to the Chinese market, medical device and IVD manufacturers will need to obtain China Food and Drug Administration (CFDA) (formerly State Food & Drug Administration or SFDA) approval. Medical device regulations in Singapore are based on recommendations of the Global Harmonization Task Force (GHTF), and are similar to regulatory requirements in the EU and other GHTF markets. Properly classify your device and submit all necessary application documents so that you can register your device with the Taiwan Food and Drug Administration (TFDA). Hong Kong's Medical Device Control Office (MDCO) - not the China CFDA - oversees medical device regulations in Hong Kong.
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FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List
Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed Rule that would amend its regulations regarding medical device establishment registration and device listing (the Proposed Rule).
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Construct and Manage the Technical File and Design Dossier
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background.
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Writing and Enforcing Effective SOPs
Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done."
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Establish and Maintain an Effective Supplier Qualification Program
FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
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Draft Guidance for Device Industry and FDA - Postmarket Surveillance
This guidance document is being distributed for comment purposes only and will be of benefit for medical device manufacturers and the document was issued on August 16, 2011. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act).
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FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List
Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.
Recorded Session Get life time access for one participant with download option!

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