Regulatory Submissions

Choosing the right regulatory pathway is the most consequential early decision a medical device manufacturer makes. The wrong choice can cost years and millions of dollars in redirected development efforts.

Software Quality Guru provides regulatory strategy consulting grounded in deep knowledge of FDA's current review practices, the evolving SaMD regulatory landscape, and practical experience across hundreds of device submissions.

We help clients evaluate pathways (510(k), De Novo, PMA, Exempt, HDE), determine predicate strategies, assess clinical evidence requirements, and develop realistic regulatory timelines — before committing to a development program.

The 510(k) is FDA's primary premarket review pathway for Class II devices, requiring demonstration of substantial equivalence to a legally marketed predicate device. De Novo provides an alternative for novel, low-to-moderate risk devices without a suitable predicate.

Our 510(k) services include: predicate device identification and analysis, submission strategy and content planning, substantial equivalence argument development, software documentation preparation (per FDA's 2023 guidance), and response to AI/AN (Additional Information requests).

For SaMD products, we specialize in software-intensive 510(k)s — navigating the intersection of device classification, software safety classification, clinical decision support (CDS) applicability, and cybersecurity requirements.

Premarket Approval (PMA) is the most rigorous FDA pathway, required for Class III devices and those that support/sustain human life. The software evidence package within a PMA is uniquely demanding.

We support PMA applicants with: Pre-Sub (Q-Sub) meeting preparation to align FDA expectations early, software documentation packages, risk management file preparation, and coordination of clinical evidence strategy.

For Breakthrough Device designated products, we help manufacturers leverage the program's benefits — more frequent FDA interaction, senior staff involvement, and prioritized review — to accelerate the development timeline without sacrificing documentation quality.

CE marking under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) requires a comprehensive Technical Documentation package demonstrating conformity with Annex I General Safety and Performance Requirements (GSPR).

Our EU services include: GSPR conformity assessment, Technical Documentation preparation, Declaration of Conformity drafting, Notified Body submission support, and Post-Market Clinical Follow-Up (PMCF) strategy.

We also assist with the EU Representative (EUDAMED) and UKCA marking requirements for manufacturers entering European and UK markets post-Brexit.