BioReg Service
BioReg Services is a boutique regulatory consultancy dedicated to helping medical device and healthcare product companies navigate regulatory and quality challenges. Their mission is to develop optimal regulatory strategies to achieve shorter approval times and greater market potential, fostering growth for their clients through professional, reliable, and innovative services. They emphasize professionalism, safety, value, and long-term relationships, aiming to be a leading regulatory provider in Israel, the EU, and the US. The company also offers specialized services for Israel medical devices registration, including declaration routes for low-risk Class I devices, and supports clients with MDR, IVDR, FDA, and other international regulations. Their expertise extends to biological and chemical evaluation, cybersecurity, biostatistics, and digital health devices, ensuring comprehensive regulatory compliance and market access.
Industries
Nr. of Employees
small (1-50)
BioReg Service
Jerusalem, Yerushalayim, Israel, Asia
Products
Clinical Evaluation Report (CER) template
A customizable template for writing Clinical Evaluation Reports to support MDR clinical evaluation requirements.
Clinical Evaluation Report (CER) template
A customizable template for writing Clinical Evaluation Reports to support MDR clinical evaluation requirements.
Services
End-to-end regulatory strategy and consulting for medical devices and healthcare products, including pathway analysis and submission planning.
Services covering device classification, technical documentation preparation/review, GSPR verification, labeling and UDI review, PMS/PMCF planning and notified body interactions.
Design and execution of literature search protocols, appraisal of clinical evidence, and preparation of Clinical Evaluation Plans and Reports (CERs).
Development of PMS plans, PMCF plans and evaluation reports, and integration of post-market data into regulatory documentation and PSUR/periodic reporting.
Preparation of 510(k), De Novo, and PMA submissions; predicate identification; inspection readiness and responses to FDA findings.
Assistance with ISO 13485 implementation, QMS gap analysis against FDA QMSR, Medical Device File (MDF) creation and QMS documentation.
End-to-end regulatory strategy and consulting for medical devices and healthcare products, including pathway analysis and submission planning.
Services covering device classification, technical documentation preparation/review, GSPR verification, labeling and UDI review, PMS/PMCF planning and notified body interactions.
Design and execution of literature search protocols, appraisal of clinical evidence, and preparation of Clinical Evaluation Plans and Reports (CERs).
Development of PMS plans, PMCF plans and evaluation reports, and integration of post-market data into regulatory documentation and PSUR/periodic reporting.
Preparation of 510(k), De Novo, and PMA submissions; predicate identification; inspection readiness and responses to FDA findings.
Assistance with ISO 13485 implementation, QMS gap analysis against FDA QMSR, Medical Device File (MDF) creation and QMS documentation.
Expertise Areas
- Regulatory compliance for medical devices (EU MDR, IVDR, FDA QMSR)
- Clinical evaluation and Clinical Evaluation Report (CER) development
- Quality management systems design and ISO 13485 / QMSR alignment
- Post-market surveillance, vigilance and PMCF planning
Key Technologies
- AI and machine learning for medical devices
- Cybersecurity risk management and SBOM
- UDI and device registration databases
- ISO 13485 implementation and FDA QMSR requirements
News & Updates
In November 2024, the EU issued guidance on the Master UDI-DI system for contact lenses, enhancing traceability and compliance.
Guidance to help manufacturers with traceability and device registration in Eudamed.
Support for obtaining CE Marking and compliance with MDR/IVDR.
Understanding FDA's new Quality Management System Regulation and Medical Device File requirements.
Support for FDA submissions including 510(k), PMA, and De Novo.
Guidance on what constitutes significant changes to medical devices under MDR.
In November 2024, the EU issued guidance on the Master UDI-DI system for contact lenses, enhancing traceability and compliance.
Guidance to help manufacturers with traceability and device registration in Eudamed.
Support for obtaining CE Marking and compliance with MDR/IVDR.
Understanding FDA's new Quality Management System Regulation and Medical Device File requirements.
Support for FDA submissions including 510(k), PMA, and De Novo.
Guidance on what constitutes significant changes to medical devices under MDR.