If you’re running a medical device startup in the USA, you already know that regulatory compliance is not just a requirement, it’s your ticket to market entry. One of the most overlooked yet vital documents in this journey is the Validation Master Plan, commonly known as VMP. This master plan is not just another checklist; […]
Medical Device Validation Master Plan (VMP) Read More »
Starting a medical device startup in the USA is an exciting but challenging venture. From navigating strict FDA regulations to meeting quality standards and gaining investor trust, entrepreneurs face multiple hurdles. Success in this industry demands not just innovation, but a clear strategy, technical know-how, and compliance expertise. Whether you’re an engineer, healthcare entrepreneur, or
5 Essential Tips to Start a Medical Device Startup Company Read More »
Medical device manufacturers seeking access to global markets often encounter complex regulatory requirements. Two widely recognized frameworks—MDSAP (Medical Device Single Audit Program) and ISO 13485—play a crucial role in demonstrating compliance with quality management system standards. While both aim to ensure the safety and effectiveness of medical devices, they are not the same. Understanding the
MDSAP vs ISO 13485: What’s the Difference? Read More »
Medical device manufacturers seeking market entry into the United States must navigate the complex landscape of FDA regulatory pathways. Two common options for classifying and marketing medical devices are the US FDA 510(k) and the FDA De Novo pathway. Understanding the key differences between these regulatory routes is crucial to ensuring a smoother approval process,
FDA De Novo vs. US FDA 510(k) Read More »
If you’re a US-based medical device manufacturer looking to expand into the UK market, MHRA medical device registration is your first step. The Medicines and Healthcare products Regulatory Agency (MHRA) governs the safety and compliance of medical devices in the UK. Since Brexit, the process has changed—making it essential to understand the UK’s post-Brexit regulatory
Guide to MHRA Medical Device Registration Read More »
In recent years, robotics in medical device manufacturing has transformed how the industry approaches precision, scalability, and compliance. As technology continues to evolve, manufacturers in the USA are increasingly integrating robotics to stay competitive, enhance product quality, and streamline regulatory compliance. But has robotics truly improved medical device manufacturing? Let’s explore how automation and robotics
Has the Use of Robotics Improved Medical Device Manufacturing? Read More »
Medical gloves are a critical part of personal protective equipment (PPE), widely used across hospitals, clinics, laboratories, and manufacturing facilities. With stringent regulatory requirements in the USA, medical glove manufacturing demands precision, compliance, and quality control at every step. Whether you’re a medical device startup or an established manufacturer, understanding the manufacturing process and associated
Medical Glove Manufacturing in the USA Read More »
For medical device manufacturers in the USA, securing FDA 510(k) clearance is often the most efficient way to enter the market. A key component of this process is selecting and justifying a predicate device—a previously approved device that your product can demonstrate substantial equivalence to. Understanding how to effectively use a predicate device is essential.
6 Tips to Use a Predicate Device Effortlessly Read More »
The US medical device market presents vast opportunities for manufacturers worldwide. However, entering this highly regulated market requires a clear understanding of FDA Medical Device Classification. Classification is the first and most essential step in the FDA regulatory pathway, as it determines the submission type, compliance burden, and testing requirements. For medical device manufacturers, startups,
FDA Medical Device Classification Read More »
As healthcare increasingly embraces digital transformation, Software as a Medical Device (SaMD) is revolutionizing patient care. However, with this advancement comes significant responsibility—especially regarding HIPAA compliance and cybersecurity. If you’re a medical device startup or SaMD developer in the USA, understanding and implementing these safeguards is critical to success and patient safety. What Is Software
Ensuring HIPAA Compliance and Cybersecurity for Software as Medical Devices (SaMD) Read More »
