Our services
We provide a wide range of professional services to meet your needs. We promise to provide every service with a smile, and to your highest level of satisfaction.
QMS Audits
ISO 13485 QMS Internal and Supplier Audits to ensure you are ready for MDR 2017/745 and IVDR 2017/746, 21 CFR 820 and MDSAP.
We have have the knowledge and skills to provide a professional and confidential service and report.
Our skills extend to ISO 14971 Risk Management, IEC 62304 Software Development Lifecycle, IEC 81001-5-1 Cybersecurity Life Cycle for regulatory compliance and risk identification and mitigation.
Clinical Evaluation and Postmarket Surveillance
Our team can provide clinical evaluation and postmarket surveillance activities for your medical device products and in vitro diagnostic products, whether using your own QMS approved templates or ours.
Software Development and Technical Documentation for Regulatory Submission
We have specialists capable of creating your regulatory submissions with in-depth knowledge and understanding of the challenges across the market to achieve faster approval to market.
Interested in our services? We’re here to help!
We want to know your needs exactly so that we can provide the perfect solution. Let us know what you want and we’ll do our best to help.