Innovenn
To optimize patient care and improve outcomes, Innovenn works to build patient-centered SaMD digital health solutions
510k submission services: To optimize patient care and improve outcomes, Innovenn works to build patient-centered SaMD digital health solutions. With more than 125 years of combined expertise, we provide a potent mix of abilities and skills to design, develop, validate, and secure regulatory approvals for innovations that enhance patient health.
From pre-submission preparations to successful marketing of medical devices, we’ll guide you through the complex approval process for new medical devices.
Offering a comprehensive suite of Human Factors and Usability Engineering services that can be utilized throughout the product life cycle, from user-centered design consulting and early-stage iterative testing, to summative validation testing and regulatory Human Factors Compliance support.
Buyer Snapshot
Best for
- Companies developing novel medical devices or SaMD products.
- Organizations seeking to navigate complex global regulatory pathways.
- Businesses requiring assistance with 510(k), De Novo, or LDT submissions.
How engagement typically works
- Collaborative strategy development.
- End-to-end submission support.
- Patient-centered development focus.
Typical deliverables
- Regulatory strategy plans.
- 510(k) submission dossiers.
- De Novo classification request documentation.
- Medical and regulatory writing documents.
- SaMD regulatory compliance guidance.
Good to know
- Best when early-stage regulatory planning is a priority.
- Best when navigating international regulatory requirements is necessary.
HQ:
Madison, US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Special 510(k) Support, Traditional 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA
Device Types Supported:
Medical device, SaMD
Supports Estar:
Yes
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Years Experience:
125
Num510k Submitted:
300
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Technology Types:
Software as a Medical Device (SaMD), Digital Health Technologies (DHTs), Clinical Decision Support Software (CDSS), Digital Therapeutics (DTx)
Engagement Models:
Consulting
Accepting New Clients:
Yes
Additional 510k_submission_services Details
Services Offered
510(k) strategy and authoring, De Novo submissions, Pre-Submission (Pre-Sub/Q-Sub) support, regulatory strategy and planning, medical and regulatory writing, SaMD regulatory services, LDT regulatory consulting.
Pathways Supported
Traditional 510(k), Special 510(k), Abbreviated 510(k), Safety and Performance Based Pathway, De Novo, Pre-Sub / Q-Sub.
Supports Estar
false
Supports Rta Remediation
false
Supports Predicate Research
true
Supports Labeling Review
false
Provides Submission Project Management
true
