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.
Bookmark this page
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.
How U.S. Testosterone Regulation Reached a Crossroads
How U.S. Testosterone Regulation Reached a Crossroads The FDA’s approach to testosterone therapy has undergone one of the most unusual and dramatic evolutions in modern drug regulation. What began as a cautious, evidence-driven posture in 2014 has, by late 2025,...
Has Industry Self-Regulation Been Effective?
Has Industry Self-Regulation Been Effective? Supplement industry self-regulation has helped in limited ways, but it has not been sufficient to ensure reliable safety. What has worked Voluntary GMP certifications (e.g., NSF, USP, Informed Choice) A minority of...
Regulatory Information
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...
Regulatory Information Management Systems (RIMS)
What Is a RIMS System? A Regulatory Information Management (RIM) system is a software solution designed to streamline and automate the management of regulatory information and processes within the life sciences industry, including pharmaceuticals, biotechnology, and...
Quality Management System Regulation – QMSR
Explore how the FDA's newly introduced Quality Management System Regulation (QMSR) is set to redefine compliance standards in the medical device industry, transitioning from the traditional 21 CFR 820 framework.Available in paperback and eBook formats on Amazon. ...
Where Regulatory and Quality Functions Intersect
At Medical Devices and Pharma, we understand that the seamless interaction between Regulatory Affairs and Quality functions is pivotal for the success of medical device and pharmaceutical manufacturers. Our expertise ensures that these collaborations not only comply...
Overview of ISO 13485
ISO 13485, Medical devices quality management systems ISO 13485, Medical devices quality management systems, is an international standard that specifies requirements for a quality management system (QMS) for medical device manufacturers. It also outlines requirements...
FDA Breakthrough Devices Program
Program assists needed products with access to US market The U.S. Food and Drug Administration (FDA) has established the Breakthrough Devices Program, a voluntary program that aims to expedite the development, assessment, and review of medical devices that demonstrate...
A Team-based Approach to an Expedited 510(k)
Getting an expedited 510(k) submission So, you have created a new medical device by following your quality system’s design controls to plan the project, define design inputs, test to verify that outputs meet inputs, and validated your production product. Now what?...