Regulatory & Compliance Perspectives

1. Wearable Medical Devices — What Should Your Contracts Look Like? 12/1/2025

   Discover from Leibowitz Law how to embed compliance and contractual protections into your wearable device contracts from the outset.

2. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

   A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

3. Duty Of Disclosure Considerations For Medical Device Patent Applicants With Parallel FDA Submissions 11/12/2025

   Understanding the crucial overlaps between FDA disclosures and patent law is important for medical device innovators seeking to protect their intellectual property.

4. A Better Interpretation Of POH In ISO 24971 11/3/2025

   Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

5. The Balkan Puzzle: Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device 10/3/2025

   The EU's Medical Devices Regulation (MDR) has introduced a new level of rigor. A sophisticated, yet practical, strategy is emerging: leveraging non-EU Balkan countries as a "pre-MDR" proving ground. 

6. EU MDR: When Products Without An Intended Medical Purpose Meet Medicinal Substances 9/24/2025

   One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an intended medical purpose but with similar risk profiles to medical devices, such as dermal fillers.

7. RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It? 9/16/2025

   The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.

8. Staying Ahead of Enforcement: Executive Strategies To Prevent FDA Warning Letters 8/19/2025

   This article focuses on practical strategies for medical device companies to strengthen their quality management systems and develop proactive programs that anticipate issues before they attract FDA action. 

9. Regulatory Planning In Early Medtech Development Is The Recipe For Success 8/18/2025

   Historically, many medtech companies have engaged with the FDA in a conservative way, providing only the minimum required to obtain clearance or approval. That mindset is no longer enough. 

10. The U.K. Now Classifies Ambient Voice Technology As SaMD 8/14/2025

    The core message of a new guidance issued by NHS England and MHRA is clear: ambient voice technology (AVT) tools that go beyond mere transcription to include summarization are to be classified as software as a medical device (SaMD).