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Get satisfactory answers to these three questions or move on. It’s too important. Choosing the right product development partner can be a daunting task. The
https://www.youtube.com/watch?v=3BH1jpXtjGI Bold Type president Jose Bohorquez shares how to add cloud connectivity to medical devices in a June 2020 presentation to the Medical Devices Group (355,000+ members). For
https://www.youtube.com/watch?v=3BH1jpXtjGI Connected wireless medical devices bring benefits to three key stakeholders in the healthcare industry: Patients, clinicians, and medical device manufacturers. For patients, connected devices
https://www.youtube.com/watch?v=kmWs3VcBgb4 Today I want to talk about the process for developing connected wireless medical devices. Let’s take it one term at a time, starting with
https://www.youtube.com/watch?v=FX8b5Bpzw4c Bold Type achieved ISO 13485 certification this year. And if you’re a medical device company looking for a product development partner, that certification can
In the realm of medical device development, ensuring the safety, effectiveness, and regulatory compliance of products is paramount. The United States Food and Drug Administration
Over the past decade, the FDA has steadily increased the degree of scrutiny applied to cybersecurity aspects of submissions. From the guidance issued on this
Implementing a Quality Management System (QMS) for a medical device startup is not just an exercise in regulatory compliance; it’s a foundational step to ensure
In today’s competitive and fast-paced market, efficiency and lean operations are essential. For startups and small businesses, setting up a full-fledged Quality Management System (QMS)
In the bustling healthcare landscape, the mHealth market—estimated between $50 billion and $110 billion USD in 2022—is more than just a promising niche. Given the
