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.
- Organizations seeking to navigate complex global regulatory pathways.
- Businesses requiring assistance with 510(k) or De Novo submissions.
How engagement typically works
- Collaborative strategy development.
- End-to-end submission support.
- Patient-centered development focus.
Typical deliverables
- Regulatory strategy documents.
- 510(k) and De Novo submission dossiers.
- SaMD regulatory compliance plans.
- Medical and regulatory written documentation.
- LDT regulatory guidance.
Good to know
- Best when early-stage regulatory planning is integrated into product development.
HQ:
Madison, US
Languages:
English
Timezones:
EST
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, SaMD regulatory services, Medical and Regulatory Writing, LDT regulatory consulting, Clinical Evaluation for SaMD, Data Governance for SaMD, Medical Device Cybersecurity.
Pathways Supported
Traditional 510(k), Special 510(k), Abbreviated 510(k), Safety and Performance Based Pathway, De Novo, Pre-Submission / Q-Sub.
Supports Estar
No
Supports Rta Remediation
No
Supports Predicate Research
Yes
Supports Labeling Review
No
Provides Submission Project Management
Yes
