MEDICAL

Medical Devices Regulatory — support unit

@ipn_medicaldevices

Coimbra
https://medicaldevices.ipn.pt
Research Services

Overview

About Medical Devices Regulatory — support unit

The MDRu team is your best partner to support you in regulatory affairs and help you take your healthcare products to market quickly and efficiently.

Composed of experienced professionals specializing in the Medical Device and Software as a Medical Device sectors, our proven track record in diverse markets, including Europe, the USA, the UK, Brazil, and Latin America, underlines our commitment to raising your company's standards of quality, safety, and compliance.

With a unique fusion of expertise in Cybersecurity, Artificial Intelligence, and Robotics, we provide detailed regulatory support to MedTech, Digital Health, and Software as a Medical Device companies.

Join us on this journey towards regulatory excellence, ensuring your company thrives in a landscape of evolving compliance challenges.

Headquarters

Coimbra

Website

https://medicaldevices.ipn.pt

Company Size

51-200 employees

Industry

Research Services

Company Type

Nonprofit

Founded

1991

Specialties

medical devices, SaMD, Regulatory Affairs, QMS, ISO 13485, MDR, CE Marking, FDA Process, 510K, ANVISA Process, UKCA, Cybersecurity, Certification Support, Regulatory Compliance, Technical Documentation, Clinical Trials, PMS, and Usability

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