- Our Services
Regulatory Affairs
- Comprehensive Regulatory Support for Global Market Access
Bioexcel Medical Device Research Organisation offer
Regulatory Affairs
EU proposed Extension of MDR transition CE for Medical Device, 510K, CDSCO.
At Bioexcel, we specialize in guiding medical device manufacturers through the complex regulatory landscape, ensuring compliance with global standards. Our end-to-end regulatory affairs services cover every stage of the product life cycle, from device classification to post-market surveillance, enabling a seamless pathway to market approval.
Why Regulatory Affairs Are Crucial
The medical device industry is governed by stringent regulations designed to ensure patient safety and product quality. Navigating these requirements can be daunting, especially with regional variations in standards like ISO, EU MDR, FDA, and CDSCO. Bioexcel simplifies the process by providing tailored strategies that align with your device’s classification, intended use, and market goals.
Key Benefits:
- Accelerate market approval with expert guidance.
- Minimize delays and non-compliance risks.
- Gain global access with region-specific expertise.
- Ensure ongoing compliance with post-market support.
Our Regulatory Affairs Services
1. Regulatory Strategy Development
Customized Pathways for Compliance
We develop comprehensive regulatory strategies tailored to your device type and target markets, ensuring efficient and timely approvals.
Key Features:
- Device classification and regulatory pathway analysis.
- Risk management and gap assessments.
- Strategic planning for multi-country submissions.
2.Regulatory Submissions and Approvals
Streamlined Documentation for Global Compliance
Our team manages the preparation, submission, and follow-up of regulatory documents, ensuring smooth approval processes.
Key Features:
- Preparation of technical files, Design Dossiers, and 510(k) submissions.
- CE marking submissions under EU MDR.
- IND, IDE, and PMA applications for FDA.
3. Device Classification and Risk Assessment
Accurate Classification for Faster Approvals
We assist in determining the appropriate classification for your device, avoiding unnecessary delays or missteps.
Key Features:
- Classification and conformity assessments.
- Hazard identification and risk management planning (ISO 14971).
- Pre-submission consultations with regulatory authorities.
4. Labeling and UDI Compliance
Ensure Accurate Identification and Traceability
Our labeling services ensure compliance with regional regulations, including Unique Device Identification (UDI) requirements.
Key Features:
- Labeling reviews for FDA, EU MDR, and CDSCO compliance.
- UDI implementation and traceability solutions.
- Language localization and translation support.
5. Post-Market Regulatory Support
Ongoing Compliance Beyond Approval
We provide post-market surveillance (PMS) services to ensure your device continues to meet regulatory and safety standards.
Key Features:
- Post-Market Clinical Follow-Up (PMCF) plans and reports.
- Adverse event monitoring and Field Safety Corrective Actions (FSCA).
- Preparation of Periodic Safety Update Reports (PSUR).
.
6.Technical Documentation Preparation
Regulatory-Ready Dossiers for Hassle-Free Approvals
Our team prepares comprehensive technical documentation aligned with global regulatory requirements.
Key Features:
- Clinical Evaluation Reports (CER) under EU MDR.
- Risk Management Files (RMF) as per ISO 14971.
- Integration of preclinical, clinical, and PMS data.
Case Studies
Case Study 1: Regulatory Approval for a Class III Orthopedic Implant
Challenge:
A manufacturer required regulatory approval for a Class III knee implant in the EU and US markets.
Solution by Bioexcel:
- Conducted a thorough gap analysis of existing technical documentation.
- Prepared a Clinical Evaluation Report (CER) aligned with MDR Annex XIV.
- Submitted a 510(k) to the FDA and a technical file for CE marking.
Outcome:
- Achieved FDA approval within six months.
- Successfully obtained CE marking under MDR.
Challenge:
An IVD startup needed CDSCO registration for their diagnostic kit for use in India.
Solution by Bioexcel:
- Managed the device classification and conformity assessment under CDSCO regulations.
- Prepared a comprehensive dossier, including performance data and risk management files.
- Facilitated the registration process with local representation.
Outcome:
- Successfully registered the product within four months.
- Enabled the client to launch their diagnostic kit in the Indian market.
Case Study 2: CDSCO Registration for a Diagnostic IVD Device
Case Study 3: UDI Compliance for a Class II Medical Device
Challenge:
A global manufacturer needed to implement Unique Device Identification (UDI) for their Class II devices to comply with EU MDR and FDA requirements.
Solution by Bioexcel:
- Conducted a labeling review and implemented UDI systems for traceability.
- Managed data submissions to the FDA GUDID database and EU EUDAMED system.
- Ensured compliance across multiple markets with localized labeling solutions.
Outcome:
- Achieved full UDI compliance within the regulatory deadlines.
- Improved traceability and streamlined market operations.
Why Choose Bioexcel for Regulatory Affairs?
Global Expertise
In-depth knowledge of FDA, EU MDR, CDSCO, and other regional regulations.
Customized Solutions
Tailored strategies to meet the unique needs of your device.
Proven Track Record
Successful approvals across a wide range of devices, including Class III implants, IVDs, and SaMDs.
End-to-End Support
From device classification to post-market compliance, we manage it all.
Help & FAQ
Frequently Asked Questions
We support regulatory submissions for major markets, including the EU, US, India, Canada, and Australia
Our team stays updated on global regulatory changes and proactively aligns your device’s documentation and processes with new requirements.
Yes, we provide comprehensive PMS and PMCF services, including adverse event monitoring, FSCA management, and PSUR preparation.
Navigate the complexities of global regulations with Bioexcel’s expert regulatory affairs services. Whether you’re launching a new device or ensuring post-market compliance, we have the expertise to guide you every step of the way
