Ya está la nueva ISO13485:2016 !!!
Ya se publico la nueva norma ISO 13485:2016 !!!
http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752
Pregunta por nuestro curso ! info@symaconsulting.com
Similar Posts
What are some best practices for Root Cause Analysis and Preventive Action?
BySylvieOur recommendation in terms of effective corrective and preventive action plans is to be very systematic in every step…. 1) First of a all VERY good definition of the defect…. If not defined correctly the action plan will not be effective. 2) Define corrections and containment actions. Make sure everybody understands the difference between those…
FDA guidance to help current manufacturing limitations due to disruptions caused by the COVID-19 – FDA to temporarily accept changes to devices approved through PMA or HDE.
BySylvieFor the duration of the public health emergency, FDA does not intend to object to limited modifications to the manufacturing of devices approved through the PMA program or the HDE program, without prior submission of the required PMA or HDE supplement or 30-day notice, where the modification does not create an undue risk in light…
Is it mandatory for the Internal quality auditors to be certified by QMS certifying agency or in house training is good enough?
BySylvieIt is NOT mandatory. However, Section 6.2.2 requires the organization to a) Determine the necessary competence for personnel performing work affecting conformity to product requirements, b) Where applicable, provide training or take other actions to achieve the necessary competence, c) Evaluate the effectiveness of the actions taken, d) Ensure that its personnel are aware of…
Medical Devices – Harmonized Standards MDD – New Listing
BySylvieIn March this year, a new list of harmonized standard was published, see the new list in this link: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/ You need to download the files now in order to see the list.
Medical Devices Regulation MDR Postponed.
BySylvieMedical Devices Regulation postponed by a year in the EU. “With patient health and safety as a guiding principle, the Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year. The goal is to have the Parliament and Council adopt the proposal by…
May Quality Newsletter
BySylvieEnglish below Noticias de Regulaciones en Dispositivos Medicos: EU publica EN ISO 13485:2012 La norma europea, EN ISO 13485:2012 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, fue publicada después de su aprobación por la CEN el 24 de Enero de 2012. Esta norma reemplaza la EN ISO13485: 2003, aunque el texto global de la…