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Compliance Commitment for Medical Consumables
At KDL, we uphold the highest compliance standards across all product lines. Our commitment extends to both standard catalog products and customized solutions, ensuring full adherence to global regulations and quality requirements.
I. Compliance for Standard Products
Regulatory Compliance
– All standard products meet ISO 13485 quality management standards and are manufactured in FDA-registered facilities.
– Products comply with region-specific regulations (e.g., EU MDR/IVDR, CE Marking, REACH, RoHS).
Documentation & Traceability
– Full technical documentation including Design History Files (DHF) and Risk Management Files (RMF).
– UDI (Unique Device Identification) implemented per FDA/EU requirements.
Quality Assurance
– Batch-specific certifications (CoC) and sterilization validations (where applicable).
– Routine audits by notified bodies (e.g., TÜV, BSI).
II. Compliance for Customized Products
Design & Development Compliance
– Custom solutions follow ISO 14971 risk management and 21 CFR Part 820 Design Controls.
– Regulatory alignment with target markets (pre-market approvals/510(k) for FDA, Technical Documentation for EU).
Client-Specific Requirements
– Material/process validations tailored to client specifications.
– Compliance with niche standards (e.g., USP Class VI, ISO 10993 biocompatibility for patient-contacting devices).
Post-Market Surveillance
– Customized PMS plans aligned with client’s QMS and regional regulations.
– Joint responsibility agreements for adverse event reporting.
III. Shared Compliance Principles
Ethical Sourcing:
– All materials comply with Conflict Minerals Regulation (EU 2017/821).
Data Security:
– GDPR-compliant handling of client-sensitive information.
Continuous Training:
– Staff certified in ISO standards and regulatory updates.
Contact Our Compliance Experts
We are committed to pursuing technological innovation and continuous improvement to build the KDL brand,
which is recognized and trusted by users around the world.
