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David Lim
President & Principal Regulatory Doctor,
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

Over the years, Dr. Lim has analyzed thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes. Dr. Lim is familiar with hundreds of medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim also is a regulatory coach, mentor, consultant and public speaker for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Dr. Lim has been actively engaged in identifying and addressing regulatory hurdles and submission issues including, but not limited to, patient-safety signals and concerns. Dr. Lim co-authored the Regulatory Affairs Professional Society (RAPS)'s online class materials for EU medical device regulations.
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Upcoming Training
This webinar is intended to help you get familiar with the FDA-compliant management of cyber security for regulatory purposes. This training session is further intended to increase our awareness that effective management of cyber security can reduce the risk to patients by reducing the likelihood of compromising cyber security whether it is intentional or unintentional. This webinar will address the best practices for cyber security management for premarket submission purposes concerning medical devices containing software as well as software that is a medical device. The speaker will walk you through the FDA compliant practices.
Live Session  Tuesday, December 16, 2014 10:00 AM PST | 01:00 PM EST,  Duration:60
Recorded Training
This webinar will help you understand the European Union (EU) Medical Device Directive (MDD), which governs medical devices. This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable Directive, which helps to assure that medical devices are safe and effective for their intended use.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to discuss important aspects of medical device design and development. Under the Federal Food, Drug, and Cosmetic Act (FD & C Act or the Act), a medical device firm is subject to design control requirements, to the extent applicable during development including clinical trials and post-marketing. Based on the FDA enforcement trends, design control failure are frequently cited in 483s and FDA warning letters.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to discuss the recent changes, hurdles, and requirements for premarket notification [510(k)] compliant with eCopy and Refuse to Accept Policy (RTA) requirements.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to discuss vaginal microbicides. FDA defines vaginal microbicides as intravaginal drug products that reduce the risk of HIV acquisition. Microbicides are applied to rectal or genital mucosa against HIV infection. Microbicides are intended to block HIV at the portal of entry, and directly at the mucosal level through delivery of high drug concentrations locally. Vaginal microbicides are designed to be self-administered products. Microbicides can be developed as vaginal formulations such as gels, creams or film, tablets, intravaginal rings (IVRs) impregnated with active product, condom impregnated with active product, etc.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with FDA Good Laboratory Practice (GLP) Inspection and Preparation – Dos and Don'ts. This webinar discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for and get ready for a successful FDA inspection: in particular, a list of Dos and Don'ts before, during and after the FDA GLP inspection will be discussed.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with how to prepare for and manage an FDA BIMO inspection integrated with emotional intelligence (EQ)-based practical and actionable guidance so that a firm's preparation and readiness for an FDA BIMO inspection can be done in a more effective, less burdensome, and easily manageable manner at all levels of organization.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

According to the recent FDA enforcement trends (including 2013), inadequate design control is frequently cited in 483s and FDA warning letters.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar will provide an opportunity to get familiar with an FDA's process to communicate with the industry early in the process for sustainable 510(k) preparation and submission.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with the Medical Device Reporting (MDR) pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act).
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with how to establish an internal audit program of the quality management systems (QMS) for medical device manufacturers in preparation for an FDA inspection or for those who are subject to ISO 13485 and/or 21 CFR Part 820.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with the recent FDA 510(k) trends, hurdles, and submission and clearance.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with how to prepare for and manage an FDA BIMO inspection integrated with emotional intelligence (EQ)-based practical and actionable guidance so that a firm’s preparation and management for an FDA BIMO inspection can be done in a more effective, meaningful and easily manageable manner at all levels of organizations.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with FDA Good Laboratory Practice (GLP) Inspection and Preparation – Dos and Don’ts. We discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for and get ready for a successful FDA inspection: in particular, a list of Dos and Don’ts before, during and after the FDA GLP inspection will be discussed.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to discuss good practices for premarket notification [510(k)] preparation and submission compliant with eCopy and Refuse to Accept (RTA) Policy requirements.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules and adequately implement a UDI system in accordance with the final rules, issued on September 24, 2013.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Have you ever wondered what regulations are applicable for drugs, biologics and medical devices during preclinical, clinical and postmarket phases? This webinar is intended to help you get familiar with the US regulations governing drugs, biologics, and medical devices including in vitro diagnostic medical devices (IVDs).
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with how to prepare for and get ready for an FDA inspection. This webinar discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for and get ready for a successful FDA inspection: in particular, a list of Dos and Don'ts before, during and after the inspection will be discussed.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to get familiar with the recent 510(k) trends and to help you implement good practices for your successful 510(k) preparation, submission and clearance.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to discuss the premarket notification [510(k)] requirements compliant with eCopy and Refuse to Accept Policy (RTA) requirements.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

FDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…"
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with the European Union (EU) Medical Device Directive (MDD) governing medical devices for CE marking. This webinar is further intended to provide guidance on the regulatory requirements set out in the MDD, which helps ensure that medical devices are safe and effective for their intended use.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to discuss the requirements for medical device developers to meet the U.S. FDA's requirements on the 510(k).
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

FDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…" This webinar will address the said current good manufacturing practice requirements to help you stay in conformity with 21 CFR Part 820.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to demonstrate how to prepare a 510(k) in a manner to facilitate the review and for successful clearance.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to present various strategies and methods to improve 510(k) submission quality. A 510(k) premarket notification submission (“510(k)”) is made to US FDA.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Medical device manufacturers, device user facilities, and applicable stakeholders are required to establish and maintain adequate procedures for handling complaints.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This webinar is intended to demonstrate how to navigate through hurdles during 510(k) processes and get it cleared from FDA.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

All medical device manufacturers are required to comply with the complaint handling requirements and medical device reporting (MDR) pursuant to the applicable statutes and regulations.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.