Casper E. Uldriks
Casper E. Uldriks
Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.
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EU Medical Devices Regulation – CE Mark Expiration and the EU Refusal of Your Exports
FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between FDA and the EU include premarket authorization (CE Mark), complaint investigations, postmarket surveillance and reports. The EU’s new Medical Devices Regulation... -
Trimming Back the Burden of FDA’s Software Regulation
Changes in the FDA’s regulation of software makes life a lot easier for medical device manufacturers. FDA faced an overwhelming challenge when it started to develop a regulatory program beyond the basic Quality System regulation and the Software Guidance... -
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FDA’s New Import Program for 2018 – Are you leading to smooth sailing or a whirlpool?
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA’s import software screening program (PREDICT) and the U.S. Custom’s ACE software program require more information from the foreign source(s). FDA’s product codes and U.S.... -
Off-Label Promotion with Truthful Information
FDA remains a mysterious in its approach to off-label advertising and promotion. The development of a reasonable and coherent regulatory program seems beyond the FDA’s capacity. What seemed to work in the past does not keep pace with a... -
FDA Regulation of Mobile Apps – Sure You are Fully Covered?
The use of mobile apps as a medical device continues to mushroom. Approximately 85% of adults use cellphones. They offer a fertile field for mobile apps used for medical purposes, some good, some not. How do you decide which... -
FDA’s Latest Import Automated Commercial Environment (ACE) Program for 2017
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA’s import software screening program (PREDICT) and the U.S. Custom’s ACE software program require more information from the foreign source(s). Information on the entry’s commercial... -
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Medical Device Software User Guide – Recovery Steps for Ransom Attacks
Medical device software and institutional enterprise systems sit in the crosshairs of hackers’ exploitation malware. The “Wanna Cry” ransom attack program is a recent global example of a cyberattack. Ransomware can shut down an entire software system, such as... -
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Avoid Reporting Cybersecurity Updates and Patches to the FDA
Is a cybersecurity patch or update a reportable event under the Reports of Corrections and Removals regulation? (21 CFR Part 806) The FDA issued a guidance document recently entitled, “Postmarket Management of Cybersecurity in Medical Devices.” It explains that... -
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Managing the FDA form “483”: Inspection Observations
This webinar is a complete guide on how to manage the FDA’s 483 observations during and after an inspection. How you respond can make or break you. Form FDA 483 is a list of observations made by FDA during... -
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Clinical Trials for The Intended Use of Software as a Medical Device
The FDA regulates standalone software as a medical device (SaMD) that is used for medical treatment or diagnostic applications. The clinical impact and corresponding risk associated with the use SaMS must incorporate a number of cross matching factors. Applying... -
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Medical Device Software – Cybersecurity vs Interoperability under the FDA
Cybersecurity and interoperability, or the lack of it, create two major problems for software users in the device industry and in the healthcare information system in general. Both problems generate anxiety and frustration for manufacturers, healthcare providers, users, and... -
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FDA’s Regulatory Download for Mobile Apps
THE — USE OF MOBILE apps as a medical device continues to mushroom. Approximately 85% of adults use cellphones. They offer a fertile field for mobile apps used for medical purposes, some good, some not. How do you decide... -
FDA’s New eMDR Requirements
Manufacturers and importers must report adverse events associated with a risk to health or death. Until now, the reports were submitted in hardcopy using MedWatch form 3500A. Managing the volume adverse event reports for industry and the FDA became... -
FDA’s New eMDR Requirements
Manufacturers and importers must report adverse events associated with a risk to health or death. Until now, the reports were submitted in hardcopy using MedWatch form 3500A. Managing the volume adverse event reports for industry and the FDA became... -
Labeling – General and Special Medical Devices Requirements
The FDA’s requirements for medical device labeling range from the typical general requirements down to very specific information about an individual product. Labeling actually covers a range of information, much more than people realize. For example, issuing a letter... -
FDA Import and Export Requirements – Don’t get caught off-guard
The FDA’s import and export requirements have become more rigorous in the past few years. The litany of problems of contaminated food and drugs raised a red flag. A few years ago, contaminated cat food manufactured abroad became a... -
FDA Regulation of Mobile Apps – Sure You are Fully Covered?
The use of mobile apps as a medical device continues to mushroom. Approximately 85% of adults use cellphones. They offer a fertile field for mobile apps used for medical purposes, some good, some not. How do you decide which... -
Training Requirements under FDA’s Quality System Regulation
Training requirements can make or break a firm’s compliance program. A weak training program becomes a weak link in a firm’s ability to make a product that conforms to FDA requirements. An effective training program should enhance and ensure... -
Cyber Security Planning for Medical Devices
How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures can... -
FDA Inspections : Get Ready Now or Get Cited Later
When FDA shows up at your front door to announce an inspection, what do you think is going to happen? More importantly, what are you going do? An ex-FDA investigator will conduct this webinar to share an “insider’s” perspective... -
Cyber Security Planning for Medical Devices
Description: How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures... -
FDA’s New eMDR Requirements
Description: Manufacturers and importers must report adverse events associated with a risk to health or death. Until now, the reports were submitted in hardcopy using MedWatch form 3500A. Managing the volume adverse event reports for industry and the FDA... -
Medical Device Recall – FDA Authority, Policy and Best Practices to Avoid and Manage
Description: Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. FDA’s recall authority and program launches you into a project of crisis management. You will learn how... -
FDA Inspections : Get Ready Now or Get Cited Later
Description: When FDA shows up at your front door to announce an inspection, what do you think is going to happen? More importantly, what are you going do? An ex-FDA investigator will conduct this webinar to share an “insider’s”... -
FDA’s Ambitious Regulation of Social Media
Description: The vehicle for communication has evolved dramatically over the past 100 years and continues to evolve at a rate faster than one can anticipate at times. Through this webinar, participants will learn how to navigate FDA’s interpretations and... -
Laboratory Developed Tests
Description: FDA has edged closer and closer to regulating IVDs developed in laboratories rather than by a typical manufacturer registered with the FDA. Public debate pits an initiative for imposing standardized regulatory controls against decades of using laboratory-developed tests... -
Managing the FDA form “483”: Inspection Observations
Description: This webinar is a complete guide on how to manage the FDA’s 483 observations during and after an inspection. How you respond can make or break you. Form FDA 483 is a list of observations made by FDA... -
FDA Inspections : Managing the Myth and the Reality
Description: FDA may inspect firms at a reasonable time, within reasonable limits and in a reasonable manner. Whether or not an inspection appears reasonable depends on a person’s point of view. FDA investigators rely on well established procedures and... -
FDA Foreign Inspections
Description: FDA’s applies U.S. regulatory requirements to foreign manufacturers during an inspection under strict time constraints. A successful inspection requires thorough preparation and practical logistics that can make or break the outcome. If you are not prepared, a failed... -
FDA Warning Letter Management Guide
Description: FDA issues a Warning Letter to tell you that you do not comply with FDA legal requirements. You have 15 working days to tell FDA how you will bring yourself into compliance. This requires drafting a plan that... -
FDA Inspection: Preparation and Management
Description: This webinar is intended to help you get familiar with FDA inspection process so that it can be prepared and managed in a proactive and effective manner. This webinar discusses practical, actionable, and sustainable guidance on how to... -
Cyber Security Planning for Medical Devices
Description: How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures... -
Managing the FDA form “483”: Inspection Observations
Description: This webinar is a complete guide on how to manage the FDA’s 483 observations during and after an inspection. How you respond can make or break you. Form FDA 483 is a list of observations made by FDA... -
Laboratory Developed Tests
Description: FDA has edged closer and closer to regulating IVDs developed in laboratories rather than by a typical manufacturer registered with the FDA. Public debate pits an initiative for imposing standardized regulatory controls against decades of using laboratory-developed tests... -
FDA’s Ambitious Regulation of Social Media
Description: The vehicle for communication has evolved dramatically over the past 100 years and continues to evolve at a rate faster than one can anticipate at times. Through this webinar, participants will learn how to navigate FDA’s interpretations and... -
FDA Inspections : Get Ready Now or Get Cited Later
Description: When FDA shows up at your front door to announce an inspection, what do you think is going to happen? More importantly, what are you going do? An ex-FDA investigator will conduct this webinar to share an “insider’s”... -
Medical Device Recall – FDA Authority, Policy and Best Practices to Avoid and Manage
Description: Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. FDA’s recall authority and program launches you into a project of crisis management. You will learn how... -
Cyber Security Planning for Medical Devices
Description: How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures... -
FDA’s New eMDR Requirements
Description: Manufacturers and importers must report adverse events associated with a risk to health or death. Until now, the reports were submitted in hardcopy using MedWatch form 3500A. Managing the volume adverse event reports for industry and the FDA... -
FDA Inspections : Managing the Myth and the Reality
Description: FDA may inspect firms at a reasonable time, within reasonable limits and in a reasonable manner. Whether or not an inspection appears reasonable depends on a person’s point of view. FDA investigators rely on well established procedures and... -
FDA Foreign Inspections
Description: FDA’s applies U.S. regulatory requirements to foreign manufacturers during an inspection under strict time constraints. A successful inspection requires thorough preparation and practical logistics that can make or break the outcome. If you are not prepared, a failed... -
FDA Warning Letter Management Guide
Description: FDA issues a Warning Letter to tell you that you do not comply with FDA legal requirements. You have 15 working days to tell FDA how you will bring yourself into compliance. This requires drafting a plan that... -
FDA Inspection: Preparation and Management
Description: This webinar is intended to help you get familiar with FDA inspection process so that it can be prepared and managed in a proactive and effective manner. This webinar discusses practical, actionable, and sustainable guidance on how to...
