Medical Device Regulatory & Quality Consulting
We provide a wide range of medical device regulatory consulting services across the full spectrum of product design and development through post-market support. Our medical device regulatory and quality consultants develop and implement global strategies to accelerate commercialization efforts.
Expertise
Our team of consultants has in-depth knowledge of medical device regulations and standards, allowing us to provide accurate and up-to-date guidance throughout the product lifecycle.
Extensive industry knowledge and practical experience in the following areas:
Cardiovascular & Peripheral Vascular Devices
Intravascular Ultrasound (IVUS)
Electroencephalography (EEG)
Software as a Medical Device (SaMD)
Mobile Application and other therapeutic and diagnostic devices
Quality Management System
We develop tailored strategies to meet your specific business goals, leveraging our expertise to accelerate time to market and optimize quality compliance.
We prepare appropriate documents to bring medical device manufacturers into compliance with the following requirements:
ISO 13485 Medical devices quality management systems, requirements for regulatory purposes
ISO 14971 Medical devices, Application of risk management to medical devices
IEC 62304 Medical device software life cycle processes
IEC 82304 Health Software
Global Regulatory Submission
With a strong understanding of global regulations, we help clients navigate international markets and ensure compliance with regional requirements.
United States FDA Submission and Clearance
Health Canada, Medical Device License
European Union EC Certificate per Regulation (EU) 2017/745 on medical devices (MDR)
United Kingdom, MHRA, Registration and UK CA mark
Japan, the Ministry of Health, Labour and Welfare (MHLW) and the PMDA
Australian Register of Therapeutic Goods (ARTG)
Establishing Authorized Representative in Europe, Switzerland and UK
©Copyright. All rights reserved.
We need your consent to load the translations
We use a third-party service to translate the website content that may collect data about your activity. Please review the details and accept the service to view the translations.