About Us
Medical Device Regulatory Consulting
Our team of regulatory consultants can help you comply with all medical device regulations and facilitate the delivery of safe and effective medical devices to the market, benefitting public health and ensuring manufacturers adhere to the highest regulatory standards.
Markets
We service small medical device companies that want to compete in the USA, Canadian, Australian, Brazilian, and European markets.
Our Services
EMG Consulting Services has experienced regulatory advisers and consultants on staff who can provide guidance in managing the diverse requirements of the US FDA and international regulations in the medical device arena. Our expertise is invaluable in accelerating the clearance process and achieving market access while maintaining compliance with global regulatory standards.
Our services include:
- Quality Management System Implementation compliant with ISO 13485:2016, FDA QMSR, EU MDR and the multiple jurisdictions taking part in MDSAP
- Internal and External Supplier Audits
- ISO 14971:2019 Risk Management Consulting
- Technical Documentation Preperation
- FDA Regulatory Submissions [510(k), de Novo, Q-subs]
- US Agent services