our approach aimed at maximizing productivity & efficiency.
modern ways of manufacturing products.
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Industry 4.0 – the systematic approach
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predictive machines
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certified factory
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service related FAQ’s
Yes, we provide full support for UDI implementation and registration in compliance with EU MDR 2017/745 and IVDR 2017/746 requirements. Our team assists manufacturers in assigning and structuring UDI-DI and UDI-PI codes based on the device classification and intended use. We also help in ensuring proper placement of UDI on labeling, packaging, and Instructions for Use (IFU), as well as preparing for UDI module submission once it becomes fully functional within EUDAMED.
Our services cover:
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UDI-DI and UDI-PI structure guidance
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Compliance with GS1, HIBCC, or ICCBBA issuing agencies
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UDI label and packaging review
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Preparation for EUDAMED UDI/Device registration module
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UDI-related documentation for your Technical File and CE submission
By integrating UDI properly, we help ensure device traceability, reduce market delays, and support full regulatory compliance across the EU.
As part of our commitment to regulatory compliance and risk management, we recommend that all non EU manufacturers have valid Product Liability Insurance when appointing us as their European Authorized Representative (EC REP). While it is not a legal requirement under MDR/IVDR for the EC REP to request proof of insurance, many Competent Authorities and Notified Bodies may inquire about the manufacturer’s liability coverage during inspections or audits. Having proper insurance also demonstrates due diligence and protects your business in the event of product-related claims in the European market. We do not provide insurance ourselves, but we can guide you on what to include based on your device risk class and market exposure.
The 510(k) file includes documents used to establish the safety and efficiency of the proposed medical device through substantial equivalence. The documents included in the 510(k) file are:
- Form FDA 3601: Medical Device User Fee Cover Sheet (MDUFC sheet)
- FDA Form 3514- CDRH Premarket Review Submission Cover Sheet: This document includes basic administrative and device information.
- 510(k) Cover Letter: This document provides a brief idea about the purpose of the submission, device, manufacturer and the U.S agent (if any).
- FDA Form 3881: Indications for Use Statement
- 510(k) Summary or 510(k) Statement: This includes a summary of the device undergoing the 510(k) clearance.
- Truthful & Accuracy Statement: This is to certify that the 510(k) submission contents are truthful and accurate and no information omitted.
- Class III Summary and Certification: If the proposed device is a Class III exempt from PMA, otherwise, this can be marked as not applicable.
- Financial Certification or Disclosure Statement: This is applicable only if clinical studies were conducted
- Declarations of Conformity and Summary Reports: Lists the voluntary consensus standards used and includes DOC to such standards.
- Device Description: This document includes the description of the device design requirements and performance specifications.
- Executive Summary: a brief description of the device & comparison table with the predicate device identified.
- Substantial Equivalence Discussion: Detailed comparison between the proposed device and the predicate device chosen.
- Proposed Labeling: Is discussed in detail to comply with 21 CFR 807.87(e) for general medical devices and 21 CFR 809.10 for IVD’s
- Sterilization and Shelf Life: This document provides details regarding the sterilization and shelf life claim being made.
- Biocompatibility: This document is applicable if the proposed device comes into direct or indirect contact with the human body tissue.
- Software: This includes the documentation for any software used in the proposed device
- Electromagnetic Compatibility and Electrical Safety- If the proposed device is powered electrically, in which case the EMC must be evaluated.
- Performance Testing – Bench: This document included details of the bench tests performed to evaluate the efficiency of the proposed device.
- Performance Testing – Animal: This document included details of the animal testing performed to evaluate the efficiency of the proposed device.
- Performance Testing – Clinical: This document included details of the clinical studies performed to evaluate the efficiency of the proposed device.
The completed FDA 510(k) file is submitted in electronic format as an e-copy to the FDA. The submission package is sent to the CDRH through registered mail or commercial delivery service.
Yes. We help you identify the most suitable Notified Body based on your device type, risk class, and review timelines and support you throughout the submission and technical documentation review process.
Key standards include:
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ISO 62366-1 – Usability engineering for medical devices.
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ISO 14971 – Risk management for medical devices.
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IEC 60601-1-6 – Usability requirements for medical electrical equipment.
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ISO 20916 – Performance studies for IVDs.
