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1. We can understand that this contract includes the provision and supply of pacemakers and Home monitoring devices, but does the available LOT 1 BUD (1,113k GBP) include the acquisition cost of these devices? 2. Within the Tender Specification LOT 1 Solvency Requirements Proof of compliance with quality standards: The Bidder must be certified in quality management according to the UNE-EN ISO 9001 standard or equivalent. For this purpose, it must present a valid certificate issued by an accredited entity, which justifies the adaptation to this regulation. - Please can you advise if ISO13485 for manufacture of the products is sufficient?

Òrgan de contractació:
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Codi d'expedient:
OBE 17-378


Resposta: 1. Yes, it does. 2. Yes, It is. ISO9001 is a standard for quality management systems that covers the requirements for the RITMOCORE procurement. Further explanation on this issue to be considered: ¿ ISO 9001 specifies requirements that are generic so that any organization, regardless of the products or services it provides, can use the standard. ISO 13485 specifies requirements for organizations involved in one or more stages of the medical device life cycle. To a large extent, ISO 13485 keeps the fundamentals of quality management systems we see in ISO 9001, adding or subtracting, where appropriate, requirements that are/are not relevant to medical devices. ¿ ISO 13485 is a quality system for the medical device industry, and it effectively covers ISO 9001 with some additional requirements. You only need to worry about ISO 13485:2016 if you're going to make and distribute medical devices. To obtain a CE marking, which indicates conformity with safety standards for products sold in the European Economic Area, medical device manufacturers must either obtain a certification with a notified body or have a quality system in place.

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