Build future AI/algorithm updates into your cleared device without resubmitting every time — or revise an existing PCCP that FDA has questioned. Covers modification protocol, performance evaluation protocol, and labeling update methodology aligned to FDA and IMDRF guidance.

Preparation for a productive FDA Pre-Sub interaction: meeting agenda development, question framing, supporting documentation review, and debrief support after FDA's written response arrives. Reduces the risk of a Pre-Sub that generates more questions than answers.

Device, software, or process change — do you need a new submission? This engagement applies FDA's 2019 Deciding When to Submit a 510(k) guidance and the PCCP framework to your specific change, and delivers a written determination with regulatory rationale you can put in your DHF.

From predicate identification through submission-ready package. Covers substantial equivalence argument development, special controls analysis, performance testing strategy, and submission structure. Suitable for first-time filers and teams preparing for a significant change submission.

Is your product a medical device — and if so, which FDA pathway applies? This engagement covers device classification under 21 CFR Part 868, intended use analysis, SaMD determination under IMDRF criteria, and a recommended regulatory pathway with rationale. Delivered as a written assessment with next-step recommendations.

Gain clarity and direction with a focused, advisor-led strategy session.

On-site audits that protect your people and your profit.

Exclusive forums where industry leaders swap insights and spark partnerships.

Your quality system is only as strong as the framework underneath it. Bowline Group designs the regulatory and QMS architecture that connects your submissions, your post-market obligations, your change control process, and your risk management file into a coherent whole — so nothing falls through the gap between departments, deadlines, or device versions.