Regulatory information
Over the years, the required knowledge base for the regulatory affairs profession has increased in complexity, breadth and depth. The Food and Drug Administration (FDA) has expanded its compliance requirements to align with internationally harmonized requirements from the European Union (EU), International Conference for Harmonization (ICH), and others.
Professional competencies
Today’s regulatory professional must have competencies in product approval requirements, quality system requirements, product design and engineering requirements, and more detailed topics depending on the criticality and type of device or drug, and affected geographies. Read more about professional regulatory competencies.
Our regulatory services
Whatever your regulatory needs, Medical Devices and Pharma provides regulatory services to companies in the medical device and pharmaceutical industries. So if you find that you would like to add a regulatory professional to your team, or a team of regulatory professionals, we can help.
Laws, regulations and regulatory documentation can be difficult to understand and interpret, especially for companies and individuals that are new to the industry or not otherwise familiar with legal requirements and guidelines. Add to that the need to stay up to date with current regulatory news, information, and trends, and the complexity of the profession becomes even more daunting.
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We recommend that you bookmark this space, because Medical Devices and Pharma will provide updates on regulatory news and events, as well as solid interpretation, analysis, and opinions to help you navigate through the national and international regulatory environments.
510(k) Submissions
Let’s connect
Consider us as a colleague and advisor if you are planning a new product or product design change, are not completely sure about compliance requirements, or have regulatory enforcement issues that you need to resolve. Some examples of the services we provide follow. And if you have any questions about these or other regulatory areas of expertise, please contact us.
October 2026 FDA Premarket Notification Clearances
510(k) Clearances – Robotics, AI and Diagnostics Lead the WatchlistOverview FDA issued 295 premarket notification clearance decisions during October of 2026 The records include 293 K-numbered submissions and two BK-numbered donor-testing submissions, all with decision...
The Abbott NEC Case and Food Risk in Vulnerable Populations
What the Abbott NEC Case Reveals About Food Risk in Vulnerable PopulationsA companion analysis on how microbiological hazards, supplements, and clinical nutrition are reshaping regulatory expectations The recent $70 million verdict against Abbott Laboratories...
Regulatory Information
China Implements a Ban on European Medical Devices
Growing China-EU Trade Conflict The medical device industry is now the latest battleground in a growing China-EU trade conflict – with potential ripple effects across global supply chains and health procurement markets. The AP reports that in an escalating trade...
The Role of a Regulatory Professional
510(k) Submissions The New QSMR Regulatory Intelligence RIM Systems Regulatory Competencies Regulatory and Quality Role of Regulatory Professionals: Core Responsibilities Regulatory professionals play a critical role in ensuring that medical devices and pharmaceutical...
Affected Regulations and Standards
QMSR-Related Regulations and Standards The transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) marks a significant shift in how medical device manufacturers align with global quality standards. This page...
ISO 9000 Clause 3 Definitions
Establishing a Common Language for Quality Management Systems ISO 9000:2015, Quality management systems — Fundamentals and vocabulary, serves as the cornerstone of the ISO 9000 family of standards, providing essential terminology and principles for quality management...
EU MDR Compliance Consulting Services
Medical Devices and Pharma offers comprehensive services to help your business meet the stringent requirements of the EU Medical Device Regulation (MDR). Our expertise ensures that your products are compliant, safe, and ready for the European market.At Medical Devices...
Extensions for EU MDR and IVDR Implementation
Initial EU MDR and IVDR transition periods extended In 2023, the European Union granted an extension for the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) due to various challenges faced by...
Implementation of the EU MDR and IVDR
A Significant EU Regulatory System Overhaul The implementation of the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) represents a significant overhaul of the regulatory framework governing medical devices and...
ICH: The International Council for Harmonization
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays a pivotal role in shaping global pharmaceutical practices, ensuring the quality, safety, and efficacy of medicines worldwide.The International Council...
The IMDRF: International Regulators
The International Medical Device Regulators Forum (IMDRF) plays a pivotal role in shaping global regulatory approaches and standards for medical devices, enhancing safety and innovation across international borders.The International Medical Device Regulators Forum...
FDA Submission and Approval Processes for 510(k)s
Learn how the FDA's 510(k) premarket notification system facilitates the introduction of new medical devices to the market, ensuring safety and compliance.Partner with us to navigate the complexities of the FDA approval process efficiently.The FDA's 510(k) process is...