MEDICAL DEVICES

Regulatory unit

Instituto Pedro Nunes (IPN) has a team specialized in regulatory affairs that will support your company in the certification of your healthcare products (medical devices, in vitro diagnostics, and/or software). With proven experience and extensive knowledge in the field, we can offer a service tailored to your organization's needs, ensuring that you achieve regulatory success efficiently.

Publicação – Short Communication

Laboratório de Automática e Sistemas

Short Communication: Regulamentos (UE) 2017/746 e (UE) 2022/112: a extensão da contagem decrescente para as alterações nos Testes Desenvolvidos em Laboratório.

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.
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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.
NZYtech
Insparya offers excellent services and the IPN gave us the support we needed to certify this demanding commitment to quality.
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Availability and Trust, two words that for BHL describe the IPN.
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