Development Support

PASB can support medtech firms at any stage of the product development cycle. As engineers, we understand the challenges faced by medtech development teams in balancing regulatory compliance with technical design and innovation.  Our goal is to work seamlessly with your technical team to plan and maintain an efficient development environment that consistently produces safe and effective medical technology within time and budget constraints. Examples of our development support services are provided below.

Let us help you implement and follow the design controls stipulated by regulators, which will ensure your technical documentation is robust, traceable, and submission-ready.  We can audit your verification and validation records and advise on any remediation activities.

We know how to perform risk management activities in accordance with ISO 14971, the international standard for medical device risk management that is recognized the FDA, Health Canada the European Union. This includes developing risk management processes, facilitating risk assessments, and producing risk management reports that will withstand regulatory scrutiny and contribute to robust product lifecycle management.

We help medical device software and mobile medical app developers implement processes that follow IEC 62304, the international standard for software development lifecycle processes required by the FDA and other regulators. We are also familiar with the latest regulatory requirements for cybersecurity and data privacy and can advise you on how to incorporate them effectively in your development activities.

We can identify usability testing requirements and generate your usability engineering file in accordance with IEC 62366, which is the standard recognized by the FDA, the EU, and Health Canada.

We have experience developing test protocols, identifying biocompatibility testing requirements, evaluating manufacturing technologies, and capital equipment sizing and costing.