Your regulatory submission timeline shouldn't depend on whether your QMS can generate a Design History File on demand. Affinity QMS gives medtech startups a fully documented, audit-ready quality system — from 21 CFR Part 820 through FDA QMSR enforcement — without the consultant overhead.
Greenlight Guru alternative · ISO 13485 software · 510(k) QMS · Medtech startup compliance · From $499/mo
Affinity QMS is built around the full regulatory stack for medical device manufacturers, from pre-submission through post-market surveillance. No bolt-ons. No separate validation packages.
FDA Quality System Regulation & QMSR (Enforced Feb 2026)
The FDA's harmonized QMSR — effective February 2026 — aligns 21 CFR Part 820 with ISO 13485. Affinity QMS maps every clause requirement to a specific module, document type, or workflow so you can demonstrate compliance at any inspection point without manual cross-referencing.
ISO 13485 — Medical Device Quality Management Systems
ISO 13485 is the global benchmark for medical device QMS and a prerequisite for EU MDR, Health Canada, and MDSAP. Affinity QMS was structured around its process-based approach — meaning your design controls, risk management, and production records all link back to clause-specific evidence without custom configuration.
Medical Device Single Audit Program
MDSAP allows a single audit to satisfy regulatory requirements across the FDA (US), Health Canada, ANVISA (Brazil), TGA (Australia), and PMDA (Japan). Affinity QMS structures your quality records and audit trails to meet the MDSAP audit model — one platform, five regulatory bodies covered simultaneously.
EU MDR, UKCA, TGA, Health Canada
Planning international market entry? Affinity QMS supports EU MDR technical documentation requirements, UKCA conformity routes, TGA regulatory submissions, and Health Canada device licensing — all within the same platform you use for FDA compliance. No additional licensing. No separate system.
Every module in Affinity QMS connects to your regulatory obligations. Activate what you need now. Add modules as you grow toward certification or pre-submission.
The Validation Protocol Engine — Built for Device Companies
Affinity QMS auto-generates IQ/OQ/PQ validation protocols for every module you activate. When your FDA auditor asks for validation documentation, you hand it over — no consultants, no canned packages, no delay. Learn more about the Validation Engine →
510(k) and PMA Submission Timelines — Documentation Incomplete When FDA Asks
You're deep in product development. Your DHF is spread across shared drives, email threads, and a spreadsheet your predecessor built. When your consultant asks for the full design history in preparation for submission, you realize the record is incomplete — and you don't have a system to close the gaps quickly. Affinity QMS builds your DHF as you develop, so it's complete by submission day.
DHF / DMR Complexity — No System to Manage Design History as You Build
The Design History File and Device Master Record require structured, traceable linkage between design inputs, outputs, reviews, verification, validation, and transfer records. Most startups manage this in whatever tool the engineering team uses — which isn't a QMS. Affinity QMS gives you a structured DHF/DMR from day one, so design control isn't a retroactive exercise.
FDA Inspection Fear — Can't Demonstrate a Functioning QMS Without Months of Consultant Work
An FDA inspection doesn't give you time to organize your quality records. When the investigator shows up and asks to see your CAPA log, your training records, your audit findings, and your risk management file — they need to be in one place, traceable, and current. Affinity QMS keeps you audit-ready continuously, not just in the weeks before an inspection.
Start with FDA compliance. Expand to international markets without rebuilding your quality system.
Unlike Greenlight Guru, Affinity QMS isn't locked to medical devices.
Greenlight Guru built a focused product for one vertical. That's a reasonable bet if your company will always be a pure-play medical device manufacturer. But the moment you expand — into a 503B outsourcing arrangement, an ISO 17025 contract lab, or a dietary supplement line — you need a second subscription, a second system, and a second validation package. Affinity QMS is built for the entire regulated landscape. Your platform scales with you, whether you expand into other verticals or grow from a 10-person startup to a 500-person enterprise. One system. One validation package. No migration costs.
See how Affinity QMS gives medical device startups a fully documented, audit-ready quality system — without the Greenlight Guru price tag or the consultant overhead.