Accortoreg
Accortoreg offers specialized 510(k) submission services, guiding medical device manufacturers through the FDA approval process. Leverage their expertise for efficient and compliant submissions.
Accortoreg is a dedicated provider of 510(k) submission services, designed to assist medical device companies in navigating the complex regulatory landscape of the U.S. Food and Drug Administration (FDA). Their core focus is on streamlining the 510(k) clearance process, ensuring that clients can bring their innovative medical devices to market efficiently and compliantly. Accortoreg's team possesses in-depth knowledge of FDA regulations and submission requirements, offering tailored support to meet the unique needs of each client. By partnering with Accortoreg, manufacturers can benefit from expert guidance, thorough documentation preparation, and strategic advice throughout the entire submission lifecycle. This allows them to focus on product development and innovation, confident in the knowledge that their regulatory pathway is being managed by experienced professionals.
Buyer Snapshot
Best for
- Small and mid-sized medical device companies
- Domestic and international manufacturers
How engagement typically works
- Trusted advisor
- Extension of regulatory team
Typical deliverables
- FDA 510(k) submissions
- De Novo Classification Requests
- PMA submissions
- EUA applications
- Establishment Registration & Device Listings
- cGMP Compliance Support
Good to know
- Best when seeking specialized guidance for FDA-regulated products.
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, Pre-Sub / Q-Sub
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Additional 510k_submission_services Details
Services Offered
Regulatory Strategy Development, Regulatory Due Diligence, Regulatory Submissions (510(k), De Novo, PMA, EUA), Establishment Registration & Medical Device Listings, cGMP Compliance & Audit Support, Regulatory Publishing, Post-Market Support, Clinical & Non-Clinical Studies.
Pathways Supported
510(k), De Novo Classification Requests, Premarket Approval (PMA), Emergency Use Authorization (EUA).
Supports Estar
Yes
Supports Rta Remediation
Yes
Supports Predicate Research
Yes
Provides Submission Project Management
Yes
