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Confinis | Startup workshop 2021

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ISO 13485 QMS development Workshop for Medical Device/IVD Start-Ups


The objective of this 8 workshops for start-ups, organised by Confinis from 25 May – 18 June, 2021, is that each participating company implements an ISO 13485:2016 QMS and receive training on the procedures. 

A QMS consists of procedures that are implemented in clearly structured SOPs (Standard Operating Procedures) and associated templates. The overarching element of this process landscape is the quality manual. An ISO 13485 certified QMS helps to not only obtain a successful product certification but guarantees an increase in transparency of the various business processes and thereby significantly reduces error and complaint rates and related costs.

Eight workshops (2-4 hours each) are at the core of this initiative. They are conducted by one of Confinis experts and together with various Start-Ups. Prior to each workshop, the respective documents, SOPs and templates are provided in an electronic format. The participants then study the material and prepare for the workshops (e.g. relevant questions for their specific needs / field of application). The interaction with our experienced consultants (which present the documents and SOPs during the workshops) and the other participants ensures seamless transition into practice and training at the same time. During each workshop there will be enough time to discuss questions regarding the implementation (customisation).

The advantages for each participating company are :

• reduced costs compared to a QMS set up by a consultant specifically for one company,
• companies gain deep understanding of the QMS during the workshops and implementation,
• participating employees are trained (training certificate will be provided),
• interaction with non-competing companies in the same industry, and
• companies can support each other with the implementation.

The series of workshops will be conducted starting from 4 participants (4 Start-Ups). The maximum number of Start-Ups is limited to 7.



25.05.2021: Regulatory strategy: introduction to medical devices regulations, qualification, classification and insights on conformity assessment (2 hours).
28.05.2021: QMS: quality manual, management responsibilities, document management, human resources, training (3 hours).
01.06.2021: QMS: design and development, risk management and usability engineering (4 hours).
04.06.2021: QMS: change management, labeling, clinical evaluation (4 hours).
08.06.2021: QMS: supplier handling, quality agreements, purchasing, incoming inspection, production, storage, packing, distribution, sales (4 hours).
11.06.2021: QMS: infrastructure and work environment, internal audits, corrective and preventive actions (3 hours).
15.06.2021: QMS: complaints, post market surveillance, vigilance (3 hours).
18.06.2021: QMS: SW lifecycle process IEC 62304, with references to cybersecurity, machine learning and artificial intelligence (4 hours).



To be determined. Depending on the COVID situation the meetings could be performed remotely.



For registration, please email to

Deadline: 21 May 2021


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