Regulatory Affairs
PASB simplifies the complexity of regulatory compliance for the global market. We guide you through every step, ensuring your medical device meets all necessary requirements.
Medical Device Services
End-to-End Solutions for Medical Device Advancement
Our services are designed to address the unique challenges of the life sciences sector, supporting medical device clients from early-stage ventures to established organizations as they navigate the complexities of product commercialization in North America and Europe.
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Quality Management Systems
Our approach to quality systems is all about establishing reliability and trust in your product and business processes. PASB helps you implement effective quality systems that comply with current regulatory requirements.
Commercial Strategy
Developing a commercial strategy with PASB means planning for your product’s market success. We help identify and navigate the pathways that will make your device a market standout.
Development Support
Technical compliance is crucial for your device’s performance and safety. PASB ensures your product adheres to the strictest technical standards, mitigating risks and safeguarding usability.
Training
With PASB’s training services, your team gains essential knowledge in medical device development and compliance. We offer insights and practices that empower and educate, making complex regulations manageable.
Small Business Solutions
Small businesses face unique challenges in the medical device industry. PASB offers customized support, helping you overcome hurdles with solutions that are both practical and scalable.