From Concept to Clearance:
Regulatory & Quality Expertise
for Medical Devices
Helping medical device companies navigate FDA submissions, regulatory strategy, and ISO 13485 quality systems—without the cost of a full-time regulatory team.
​
With over 25 years of regulatory affairs and quality experience, NovoMedTek supports startups and established manufacturers from concept to clearance.
Regulatory Strategy
Services include:
-
Device classification and regulatory pathway strategy
-
Predicate device identification and regulatory landscape analysis
-
FDA pre-submission planning
-
De Novo and 510(k) strategy
-
Global regulatory roadmap development
FDA & Global Submission Support
Our team prepares and manages regulatory submissions from start to finish.
-
FDA 510(k) preparation and submission
-
De Novo submissions
-
Technical documentation for global markets
-
Gap assessments and remediation
-
FDA deficiency response support
Quality Systems & Compliance
Build a scalable quality system that supports growth and regulatory compliance.
-
ISO 13485 Quality Management System development
-
FDA QMSR readiness
-
SOP development and implementation
-
Design controls and risk management
-
Internal audits and compliance support
Lifecycle Regulatory Support
Regulatory compliance does not stop at clearance.
We support companies throughout the product lifecycle.
-
Change control strategy
-
Post-market surveillance planning
-
Global registrations and renewals
-
Regulatory impact assessments
-
Ongoing advisory support
ENGAGEMENT OPTIONS
We offer flexible consulting, tailored to your needs.
-
Hourly consulting
-
Project-based submissions
-
Monthly regulatory advisory retainers
-
Custom regulatory strategy packages
WHO WE WORK WITH
NovoMedTek supports:
-
Medical device startups preparing for their first FDA submission
-
Early-stage companies seeking regulatory strategy
-
Established manufacturers expanding into new markets
-
Companies implementing or improving quality systems
WHY CLIENTS WORK WITH US
Faster Market Access
-
Clear regulatory strategy helps avoid costly delays
Investor & Board Ready
-
We help companies present a credible regulatory roadmap to investors and partners
Flexible Expertise
-
Access senior regulatory leadership without hiring a full-time team