LAS

Services

Regulatory Support for Medical Devices

We help organisations navigate regulatory requirements and prepare medical devices for market approval.

Our services include:

  • support in obtaining CE mark under the Medical Device Regulation (MDR) and the AI Act
  • implementation/adaptation of Quality Management Systems aligned with ISO 13485, MDR, AI Act and 21 CFR 820
  • elaboration/revision of Technical Documentation (including BEP/BER, CEP/CER, Risk Management, PMSR and PSUR)
  • assist with US market access, including preparation/revision of pre-submissions, 510(k), De Novo, and PMA
  • regulatory consulting
  • internal audits
  • specialized training
 

We help organisations manage regulatory complexity, ensuring their technologies are safe, compliant and ready for market.

IPN provided exceptional, highly efficient support throughout our FDA Q-submission process. We were so impressed with their regulatory expertise and rapid communication that we have confidently chosen to partner with them again for our upcoming 510(k) submission.”

“Nootric appreciated the support provided by the MDRu team and the constructive collaboration throughout the process.”

“Iniciámos a nossa colaboração com a Unidade de Apoio Regulamentar do IPN com um pequeno serviço, tendo ficado plenamente satisfeitos com o rigor técnico, profissionalismo e a qualidade do acompanhamento prestado, razão pela qual decidimos reforçar esta parceria e continuar a trabalhar em conjunto.”