<h1>Med-device CDMO expands ISO Class 8 cleanroom; compliance with ISO 13485, 21 CFR 820, ISO 14971, MDR risks</h1> A manufacturing company announced plans to exhibit advanced medical-device production services at an industry event, emphasizing end-to-end CDMO offerings, regulatory consulting, and compliance with ISO 13485, 21 CFR 820, ISO 14971 and MDR requirements. The firm is expanding capacity with a new ISO Class 8 cleanroom to meet demand, which may implicate facility licensing, quality system validation and environmental permitting. Cross-border documentation and sterilization services raise regulatory and import/export compliance considerations. Collaboration with a design consultancy highlights potential liability allocation, intellectual property and contractual risk issues in turnkey device development.