"Navigating Your Regulatory Pathways to US FDA with Expertise and Precision"

Our expertise lies in:

  • Assisting with 510(k) Clearance and PMA Approvals

  • Managing Pre-submission Correspondence

  • Offering guidance on De Novo classifications

  • Assisting with Investigational Device Exemptions (IDE) applications and Breakthrough Designations

US FDA

US FDA

At Gladiolus, we specialize in guiding medical device companies through the complexities of regulatory compliance. With our expert guidance, you can ensure compliance with all US FDA requirements, streamline the approval process, and bring your innovative medical devices (including in vitro Diagnostics Devices) to the U.S. market efficiently and effectively.

Obtaining US FDA approval can be challenging

Our Services

Regulatory Strategy and Consultation

  • Provide expert guidance on regulatory pathways, submissions, and compliance strategies for global markets.

  • Navigate complex regulations of US FDA for 510(k) clearance, PMA Approval, and De Novo Classification.

Regulatory Submissions Support

  • Prepare, review and submit regulatory documentation to US FDA acting as your US Agent.

  • Ensuring compliance to regulatory requirements for 510(k) application, PMA Application, Pre-submission, De Novo classification, IDE applications, FDA Breakthrough Designations, etc.

Classification, Labeling and Design Control

  • Assist in product classification according to US FDA’s regulatory requirements.

  • Develop compliant product labels, Instructions for Use (IFUs), and packaging inserts.

  • Consulting for product design & development and Assist in significant design change impact assessment.

Testing Requirements and Safety Assessment

  • Discover the testing essentials for your device, including biocompatibility testings, electrical safety testings, and clinical evaluations, receiving guidance on the precise safety and performance standards best suited to its specific type.

Gap Analysis

  • In-depth assessment of your current technical documentation, and compliance practices against the relevant regulatory standards.

  • Identify deficiencies in Technical Files, DMRs, DHRs, and labeling.

  • Develop a tailored plan to bridge gaps.

Risk Assessment and Mitigation

  • Implement risk management processes based on ISO 14971. Identify, assess, and mitigate risks associated with medical devices.

  • Develop risk management plans to ensure product safety and regulatory compliance.

Post-Market Support

  • Provide support to implement processes for post-market surveillance, complaint assessments, CAPA, Medical Device Reporting and Device Recalls.

  • Provide comprehensive review of promotional/marketing materials and website contents in compliance with regulatory requirements

Connect With Us Now

We are eager to collaborate with you on your regulatory needs. Connect with us today for tailored solutions designed to meet your unique requirements.