Who We Serve: Business Model
Startups and First-Time Submitters
A device startup does not need every procedure on day one, but it does need the right ones before design work produces the evidence a submission will rely on. Building in the wrong order leaves a team reconstructing design history months later. We help founders build a quality system in phases that match the product's stage.
Standards and Regulations to Know
- ISO 13485Quality Management Systems for Medical Devices
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- ISO 14971Risk Management for Medical Devices
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- 21 CFR Part 812Investigational Device Exemptions
- IEC 62304Medical Device Software Lifecycle Processes
- IEC 62366-1Usability Engineering for Medical Devices
Typical Regulatory Exposure
The first exposure is design and development. Once a concept becomes a product the company intends to submit, design planning, design inputs, risk management under ISO 14971 and verification records need to be captured as the work happens. Testing done before those controls existed can sometimes still be used, but it usually needs a documented assessment showing it is valid for the final design.
The second is the submission. A 510(k), De Novo request or PMA rests on design outputs, verification and validation, biocompatibility, software documentation and labeling that all trace back to the design file. Clinical studies of significant risk devices need an investigational device exemption under 21 CFR Part 812 and can bring bioresearch monitoring inspections that reach sponsors as well as sites.
The third is commercial launch. At that point the company registers its establishment and lists its devices under 21 CFR Part 807, and the QMSR applies to the manufacture of finished devices. Production controls, supplier controls, complaint handling and medical device reporting all need to be working, because from then on they are open to FDA inspection.
Where Audits Find Gaps
- 01
Design History Reconstructed After the Fact
Requirements, test results and design decisions live in slide decks and shared drives, with nothing showing when they were made or who approved them.
- 02
Risk Management Started at Submission
The risk file was written to support the submission rather than to guide the design, so risk controls do not trace to design inputs or verification.
- 03
Template Procedures the Team Does Not Follow
A full QMS template was adopted at once, and the team now has procedures for processes it does not yet run, each one a potential finding.
- 04
Prototype Suppliers Carried Into Production
Critical suppliers chosen for prototypes moved into production without evaluation records or quality agreements.
- 05
Software Documentation Behind the Code
Device software was built quickly by a small team, with requirements, architecture and verification records left until the submission deadline.
Relevant Standards and Regulations
- ISO 13485Quality Management Systems for Medical Devices
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- ISO 14971Risk Management for Medical Devices
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- 21 CFR Part 812Investigational Device Exemptions
- IEC 62304Medical Device Software Lifecycle Processes
- IEC 62366-1Usability Engineering for Medical Devices
Relevant Services
QMS Build for Startups (Phased)
A QMS built in phases for a device startup: design controls and risk first, the rest before you need it.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
ISO 13485 Certification Readiness
Prepare your QMS, records and people for a certification body's Stage 1 and Stage 2 audits.
Ongoing Advisory and Continuous Readiness
Periodic re-assessments, a live action plan and yearly mock inspections that keep readiness from decaying.
Audits and Inspections You May Face
ISO 13485 Certification Audit (Stage 1 and Stage 2)
The Stage 1 and Stage 2 audits a certification body runs before granting ISO 13485 certification.
FDA BIMO (Clinical Investigation) Inspection
FDA inspection of a clinical investigation's sponsor, monitors, investigators or IRB under 21 CFR Part 812.
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
Questions
When does a startup need design controls?
As soon as the work is meant to become a product you will submit or sell. Feasibility work before that point can be less formal, but the transition should be documented so the design file has a clear starting point.
Should we pursue ISO 13485 certification early?
It depends on your markets and partners. Certification is not an FDA requirement, but it is expected in many markets outside the US and by some distributors and partners. A phased build lets you add what certification needs once the business case is clear.
Can we use test data from before our QMS existed?
Often, if you can show the data are valid for the final design. That typically means documenting what was tested, in what configuration and under what conditions, and assessing whether later design changes affect the result.
What does the platform do for a small team?
It gives you one place for the documents you already have, shows what is missing for your stage and turns advisor-reviewed findings into an action plan with owners and due dates. It is built so a small team can see what to do next without standing up a large eQMS first.
Startups and First-Time Submitters
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
