Sigma Biomedical
Expert FDA 510(k) Regulatory Consulting | Biomedical Engineering Expertise | 12 Years Experience
Sigma Biomedical is a dedicated consulting firm providing expert FDA 510(k) regulatory consulting services. With 12 years of experience and deep regulatory knowledge combined with biomedical engineering expertise, they empower medical device companies to successfully navigate complex FDA regulatory pathways and achieve 510(k) clearances. Their focused approach ensures efficient and effective support for your device's journey to market, offering strategic guidance and risk management.
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA 510(k) clearance.
- Companies needing assistance with regulatory strategy and documentation.
How engagement typically works
- Consultative approach to compliance evaluation.
- End-to-end support for submission preparation and filing.
Typical deliverables
- Completed 510(k) submission package.
- Regulatory compliance assessments.
- Filing strategy recommendations.
Good to know
- Best when requiring specialized biomedical engineering and regulatory expertise for 510(k) submissions.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Predicate Research & Substantial Equivalence Strategy, 510(k) RTA Remediation / Refuse-to-Accept Fix, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Device Types Supported:
Medical device
Supports Predicate Research:
Yes
Years Experience:
12
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Engagement Models:
fixed_fee
Accepting New Clients:
No
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
