B+Solutions is dedicated to staying at the forefront of advancements, regulations, and innovations in the medical device industry. We provide comprehensive support to ensure the performance, safety, and regulatory compliance of medical devices, delivering tailored solutions to meet the needs of all economic operators in the field.
Our expert team at B+Solutions offers a range of specialized services, including:
- Compliance with the EU MDR 2017/745 Medical Device Regulation
- Development and implementation of Quality Management Systems
- CE Certification support
- Technical documentation preparation
- Clinical evaluation and more
In addition to helping our clients navigate complex regulatory landscapes, B+Solutions is committed to elevating industry standards to new heights.
Our Services
Regulatory Services
Quality Management System Consulting
Clinical Services
Engineering and Design
Testing and Validation Services
Manufacturing and Supply Chain Optimization
Business and Market Services
Cybersecurity and IT
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The Value of Partnering with B+Solutions
At B+Solutions, our team of medical device experts is dedicated to delivering swift, effective solutions that drive results. We conduct comprehensive research on key areas, including the 2017/745 MDR Medical Device Regulation, medical device design, clinical data evaluation, risk analysis, CE certification, and permit and registration procedures.
In the medical device industry, quality and human health are fundamentally interconnected. Since medical devices directly impact healthcare, companies must stay informed and compliant. B+Solutions provides expert training to enhance corporate awareness, empowering companies to prioritize safety, efficacy, and regulatory compliance.
A professional consultancy service not only ensures compliance with these standards but also prevents costly delays and financial setbacks. By proactively investing in medical device consultancy, companies can effectively mitigate non-compliance risks—avoiding penalties, usage restrictions, and other regulatory hurdles—thereby facilitating a seamless market entry and long-term success.
