Regulatory Affairs

Bioexcel Medical Device Research Organisation offer

Regulatory Affairs

EU proposed Extension of MDR transition CE for Medical Device, 510K, CDSCO.

Bioexcel supports medical device companies in achieving regulatory compliance and gaining access to global markets. The expertise and guidance provided help clients navigate the complexities of different regulatory systems and ensure their products meet the necessary safety and performance standards, thereby expediting market access and commercial success.

Assistance in Preparing Regulatory Submissions:

Bioexcel provides expert guidance and support in preparing comprehensive regulatory submissions that are required for approval, clearance, or marketing of medical devices. This includes assembling all necessary documentation, ensuring compliance with relevant regulations, and preparing submission packages that meet regulatory authorities’ requirements.

Bioexcel team works closely with regulatory authorities, such as the CDSCO, US FDA,EU,MHRA,TGA,EUDAMED and their international counterparts, to facilitate communication and responses to queries or requests for additional information. This includes managing interactions throughout the submission and review process.

International Market Access:

Expertise in Navigating International Regulatory Requirements: Bioexcel offers specialized knowledge of international regulatory requirements and standards, helping clients navigate the complexities of accessing global markets. This includes understanding the regulatory nuances in different countries or regions and ensuring compliance with their specific requirements.
Market Entry Support: Bioexcel assists clients in formulating market entry strategies that take into account the regulatory landscape of each target market. This may involve tailoring submissions, labelling, and quality assurance processes to meet the unique requirements of each country or region.
Risk Assessment and Mitigation: Conducting risk assessments to identify potential regulatory hurdles and challenges in different markets. Bioexcel helps clients develop strategies to mitigate these risks and streamline the regulatory approval process.

Bioexcel offer expert guidance & regulatory submission. Our team is highly qualified & dedicated for for all types of medical Device & diagnostics throughout the product life cycle, providing training, licensing and certification.

Europe:

CE for Medical Device
Medical Device Technical File
Risk Management
General Safety & Performance requirement
Instruction For Use of IFU & labels
CE for in-vitro diagnostic device
CE for personal protective equipment

(EU proposed Extension of MDR Transition Period Bioexcel support all kinds of PMCF (Post Market Clinical Follow-up studies)).

India:

Product Classification
Test License
Manufacturing License
Import License
Post approval Changes

USA:

US FDA 510k
NIOSH certification
US FDA Label
Drug Master File

Help & FAQ

Frequently Asked Questions

How Will Regulatory Affairs Services at Bioexcel Benefit My Medical Device Project?

Regulatory affairs services at Bioexcel are designed to streamline the regulatory pathway for your medical device. Our experts provide guidance on regulatory strategy, prepare and submit necessary documents, and facilitate interactions with regulatory authorities. By ensuring compliance and expediting approvals, we help your device reach the market faster, saving you time and resources.

What Regulatory Pathway Is Appropriate for My Medical Device, and How Do You Determine It?

Bioexcel's experienced regulatory team evaluates your device's classification, intended use, and the regions you plan to enter. We determine the most suitable regulatory pathway, which may include 510(k) submissions, Premarket Approval (PMA) applications, or other pathways. Our goal is to align your device with the most efficient and compliant route to market.

Can Bioexcel Assist in Preparing and Submitting Regulatory Documents to Ensure Approvals?

Yes, Bioexcel provides comprehensive support in preparing and submitting regulatory documents. We work closely with your team to ensure all necessary documentation, including 510(k)s, PMAs, and Design Dossiers, is complete, accurate, and in compliance with regulatory standards. This assistance is critical to obtaining timely approvals.

How Does Bioexcel Ensure Timely Approvals and Regulatory Compliance for Medical Devices?

Bioexcel's team is well-versed in regulatory requirements and agency expectations. We maintain open communication with regulatory authorities and implement efficient processes to ensure timely approvals. Additionally, our ongoing compliance support, including post-market surveillance, helps you maintain regulatory compliance throughout the product lifecycle.

What Is Bioexcel Experience with Regulatory Authorities and Navigating International Regulatory Requirements?

Bioexcel has a strong track record of successful interactions with regulatory authorities, including CDASCO, the FDA and international regulatory bodies. Our team is experienced in navigating the complexities of global regulatory requirements, ensuring your device's compliance and market access, no matter where you intend to distribute it.

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