About us
Instituto Pedro Nunes
IPN has a multidisciplinary team capable of providing complementary skills by carrying out RTD, innovation, entrepreneurship and technology transfer activities in the fields of Digital Transformation and Healthcare, as well as in the development, validation, evaluation and regulatory support of telemedicine and tele-rehabilitation solutions.
Services
We will support you on this journey towards excellence and innovation in the healthcare sector.
With specialists in Global Markets such as FDA, CE Marking, ANVISA and UKCA; Cybersecurity; Artificial Intelligence and Robotics, we are able to provide an appropriate solution for each type of product – Medical Devices, in vitro Diagnostics Medical Devices and Software as Medical Devices.
Why contract our services?
In the last three years we have successfully supported more than 70 companies from the European Union, the United Kingdom and Brazil in obtaining the prestigious CE marking and FDA approval for more than 150 medical devices, in vitro diagnostic medical devices and software as medical devices. In addition, we have provided regulatory training to more than 300 participants, thereby improving the internal knowledge base of these companies.
+100
Companies supported
+400
Participants
+200
Medical Devices and IVD
+3
years experience
Customers
Testimonies
The Regulatory Support Unit team was very important at the start of Ophiomics and its QMS. Between meetings to analyse documentation, the need for records that we didn’t have as mandatory and all the regulatory support in terms of instruction manuals, boxes and labels. Legislation is never clear-cut and having specialised support was and continues to be fundamental for Ophiomics, which is now certified according to ISO 13485 and already has a IVD CE marking on an in vitro diagnostic medical device.
We are pleased to witness the remarkable capacity of the IPN’s Medical Devices Regulatory unit, which offers a personalized service of exceptional quality. The team’s experience, professionalism and dedication have been fundamental to the success of our organization.
Insparya offers excellent services and the IPN gave us the support we needed to certify this demanding commitment to quality.
Availability and Trust, two words that for BHL describe the IPN.
MDRu supported the regulatory path of: Cardio.AI: AI-assisted solution for affordable remote medical-grade cardiac diagnostics. The deepest and the most accurate ECG diagnostic delivered in a short time.
O apoio por parte da MDRu foi crucial para nos ajudar a navegar pelo mundo dos assuntos regulamentares. Deu-nos a segurança e a confiança para certificar o nosso dispositivo e estar um passo mais perto da entrada no mercado europeu.
MDRu supported the regulatory path of IPLEXMED that is developing NexaGuard, a first in class, portable, lab-grade and easy-to-use platform for the diagnosis at the ER of multiple infections and associated antimicrobial resistance in just 20 min.
A MDRu foi fundamental na agilização do processo de comunicação com a FDA com vista a classificação da tecnologia InEye® pelos peritos desta autoridade regulamentar.
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Partnerships
