We turn early concepts into functional systems ready for testing, validation, and
transfer into manufacturing. Our team is equipped to manage projects and
programs to meet regulatory expectations and prepare for scale-up.
Our Expertise
Design & Development
We bring innovations to life
with manufacturing in mind.
Device Design & Engineering
Our design and development team transforms product ideas into functional systems. These efforts support a smooth transition into manufacturing, with outputs aligned to long-term scale-up.
Cross-functional engineering teams integrate manufacturing expertise to design sophisticated products optimized using Design for Manufacturing principles (DFM).
We begin Design History File preparation early and guide the process to meet strict U.S. and global regulatory requirements.
Prototyping
We rapidly develop in-house prototypes that help clients test early concepts and make quick, informed decisions. These models combine mechanical, electrical, and software elements to simulate real-world use.
We evaluate prototypes for form, function, and usability in relevant settings, with early results guiding targeted design refinements.
Projects move from initial sketches to integrated models built for iteration, supporting faster feedback and decision-making throughout development.
Verification and Validation Testing
We use testing to confirm whether a device meets safety, performance, and regulatory requirements. Our development team supports validation and pre-compliance testing throughout development.
In-house testing methods support international testing standards to ensure success in compliance testing.
Teams use proven best practice tests and create custom test protocols as needed.
Regulatory
Expert guidance
through every stage
of development
Our team supports clients with the regulatory planning, preparation, and interaction needed to bring products to market and maintain long-term compliance. Our support includes preparing documentation, managing regulatory communications, and supporting submission processes for medical devices and combination products.
Regulatory Filings & Interactions
We support 510(k) submissions, CE Technical Files, FDA Q-submissions, and preparation for meetings related to IND and NDA pathways.
Medical Device Development
We help devices obtain regulatory approval faster by creating strong strategies that align development with appropriate regulatory pathways across global markets.
Combination Product Development
Our streamlined quality system and drug handling capabilities accelerate development for drug delivery devices and combination products.
