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Essential Advice for Medical Device Compliance with Medical Device Consulting Services
Understanding the Regulatory Landscape with Medical Device Consulting Services. Regulations vary by region, but the core principles remain consistent: safety, efficacy, and quality. For example, in the UK and Europe, the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) set stringent requirements. In the US, the FDA’s Quality System Regulation (QSR) governs device manufacturing and controls.
BC Regulatory Blog
Dec 23, 20254 min read
Registering Medical Devices in Europe: Key Steps for Success
Navigating the regulatory landscape for medical devices in Europe can feel daunting. However, with the right approach and clear understanding, it becomes a manageable process that opens doors to one of the world’s most significant healthcare markets. I want to share practical insights and step-by-step guidance to help you confidently move through the process of registering medical devices in Europe. This will empower your company to bring innovative products to patients faste
BC Regulatory Blog
Dec 22, 20254 min read
Streamlining Medical Device Market Access in the UK with Medical Device Entry Consulting
Navigating the UK medical device market can be a complex journey. For biotech and SME companies, understanding the regulatory landscape is crucial to efficiently and safely bringing innovative products to patients. As someone deeply involved in this field, I know that medical device entry consulting is not just about ticking boxes; it’s about creating a strategic pathway that accelerates market access while ensuring compliance and patient safety.
BC Regulatory Blog
Dec 11, 20254 min read
AI in Pharma 2025: Who’s Leading the Charge and Why It Matters
The convergence of artificial intelligence and pharmaceutical innovation is no longer a distant vision; it’s today’s reality. With a projected market size of $116.49 billion by the end of 2025 and a 27% compound annual growth rate (CAGR), AI in pharma is reshaping everything from drug discovery to diagnostics.
Camilla Costa
Jul 4, 20253 min read
Unlocking the Potential of Machine Learning Frameworks in Medical Device Innovation and Expertise
In today's fast-paced world, technology is making remarkable changes across many sectors. Machine learning (ML) frameworks stand out as a...
Camilla Costa
May 20, 20254 min read
Navigating the Unknown: Key Principles of Good Machine Learning Practices in Medical Device Development
The rapid growth of machine learning (ML) in recent years has introduced new possibilities in healthcare. These advancements offer the...
Camilla Costa
Mar 4, 20254 min read
Understanding the FDA Digital Health Software Precertification Program and Its Impact on Your Innovations
The rapid growth of technology in healthcare has opened new doors for innovation, especially in digital health software. Developers are...
Camilla Costa
Jan 9, 20253 min read
Unlocking Key Resources for Navigating FDA and EU Regulations in Digital Health
The digital health landscape is evolving quickly, thanks to advances in technology like artificial intelligence (AI) and machine learning...
Camilla Costa
Nov 6, 20245 min read
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