Bioexcel Medical Device Research Organisation offer
Regulatory Affairs
EU proposed Extension of MDR transition CE for Medical Device, 510K, CDSCO.
Why Regulatory Affairs Are Crucial
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.
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.
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.
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.
CASE STUDY
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.
- 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.
Case Study 2: CDSCO Registration for a Diagnostic IVD Device
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.
- 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 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.
- 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.
