Product Development

Streamline your commercialization efforts

Regulatory compliance is essential to effective product development in the medical device industry. In our experience, a strong technical team is maximally effective when partnering with an experienced Regulatory & Quality team. By ensuring the technical team is supported throughout the commercialization process, manufacturers can ensure technical file development in compliance with regulatory requirements and streamline regulatory submissions for faster market authorization.

How can Brooke & Associates help your business?

We can serve as an embedded resource or supplement the existing Regulatory & Quality team to work closely with the technical team to meet compliance requirements contemporaneously and throughout the product development process.

Example services include:
• Serving as interim regulatory & quality personnel and contributing to day-to-day research, quality, and product development activities
• Building, auditing, and improving quality management systems (consistent with ISO 9001:2015, ISO 13485:2016, 21 C.F.R. Part 820, ISO 14971:2019, IEC 62304:2006/A1:2015, and ISO 14155:2020)
• Advising on CAPA, nonconformity, complaint handling, adverse event reporting, and post-market surveillance best practices
• Supporting clients during quality audits from regulators and customers
• Developing pre-clinical and clinical research strategies, particularly for AI/ ML-based software and Virtual/Augmented Reality technologies