Sigma Systems offers a wide range of regulatory services, expert guidance and support for medical device companies, ensuring compliance and regulatory success. SIGMA SYSTEMS is certified according to ISO 13485 and ISO/IEC 27001. Scope of SIGMA SYSTEMS QMS/ISMS is providing consulting, education and auditing services through: --> regulatory services and consulting within the medical devices quality management systems, --> competence management, knowledge management, learning and e-learning, assessment of learning services and people development outcomes, --> services and consulting related to Information security controls within Information security management systems, cybersecurity, data and privacy protection, to clients in the medical device industry which includes regulatory support in research, design and development of medical and in vitro diagnostic medical devices, software as medical device (SaMD), development and maintenance of QMS and eQMS, support during launching on the market and support in production and post-production processes.
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This year MEDICA - Leading International Trade Fair was a tremendous experience and a big opportunity to connect with our partners and clients! We are excited about future partnerships and the upcoming projects and are looking forward to following up with all the fantastic new connections we made! See you next year!
This year MEDICA - Leading International Trade Fair was a tremendous experience and a big opportunity to connect with our partners and clients! 🌎🌏🌍 The outstanding med tech and IVD solutions showcased include a lot of regulatory hurdles but achieving compliance is easier with SIGMA SYSTEMS & SigmaTech Nordic. We shared our impressions about MEDICA - Leading International Trade Fair through the official video podcast. https://lnkd.in/egZa269U We are excited about future partnerships and the upcoming projects and are looking forward to following up with all the fantastic new connections we made! See you next year! A big thank you to the SIGMA team for providing great regulatory and QA service support, overcoming regulatory challenges and fulfilling the clients' and partners' needs. Thank you very much to all our clients, partners and friends for your effort put into supporting us! SigmaTech Nordic & SIGMA SYSTEMS Your path to medical device compliance!
Third great day at MEDICA - Leading International Trade Fair. Come meet us in Hall 13/C48 to discuss how we can help you be compliant! SIGMA SYSTEMS & SigmaTech Nordic Your path to medical device compliance!
We shared our impressions about MEDICA - Leading International Trade Fair through the official video podcast. 💪🚀🚀🚀 Milos Ilic SigmaTech Nordic & SIGMA SYSTEMS https://lnkd.in/egZa269U
Another great day at MEDICA - Leading International Trade Fair with so many people from all over the world in need of regulatory support. Come meet us in Hall 13/C48 to discuss how we can help you be compliant! Milos Ilic, Jacob Eric Nielsen & Aleksandar Siskovic 💪 SigmaTech Nordic & SIGMA SYSTEMS 🚀🚀
Medical Device Consultant & Auditor, 12+ years in medical device industry, certified lead auditor for ISO 13485, certified MDSAP auditor, certified lead auditor for ISO 9001, IEC 62304 consultant, ISO 14971 consultant
The first day of MEDICA - Leading International Trade Fair was great, we are very excited to be here and would like to invite you to visit our booth at hall 13/C48. SigmaTech Nordic & SIGMA SYSTEMS Jacob Eric Nielsen, Milos Ilic, Aleksandar Siskovic #medicaldevice
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DTU - Technical University of Denmark A new fund focusing on deep tech startups receives DKK 185 million from the European Investment Fund (EIF) and DKK 100 million from Export and Investment Fund of Denmark (EIFO). In total, the foundation thus has a budget of DKK 600 million DKK. PSV Hafnium is part of DTU's subsidiary PSV Foundry. SIGMA SYSTEMS team 🚀 Read more https://l.dtu.dk/4eY6gSH Læs mere https://l.dtu.dk/3TZF3qT
MEDICA 2024 Visit our booth during MEDICA for insights about placing medical devices on the EU market. We have scheduled a preliminary program of up to 20 min. sessions for you to pick the right time to come and visit us. https://lnkd.in/duHp8s8U