CORE EXPERTISE
QUALITY MANAGEMENT SYSTEM
Please let us know if you need help developing a QMS, SOPs, Subcontractor/Supplier verification and validation programme for your company in line with ISO 13485, 9001, MDSAP, and 21 CFR Part 820. We'll customize it to meet your individual needs.
EU MDR & IVDR, ARTIFICIAL INTELLIGENCE, SaMD, DIGITAL HEALTH TECHNOLOGY
We offer a complete solution for obtaining CE certification and FDA approval. We specialise in dealing with start-ups, AI-based businesses, SaMDs, and small businesses. We can assist you with your Technical File, Clinical Evaluation, Risk File, General Safety Performance, Post Market Surveillance, IFUs, Product Label Verification, Biological Evaluation, and 510(k) submission.
TRAINING AND SCIENTIFIC WRITING
If you require scientific-technical assistance in developing quality assurance or regulatory documents or clinical content for your organisation, editing content, reviewing labels and brochures, blogs, checklists, reviewing technical documents related to medical devices and IVD, and so on, we are highly qualified to help. We also offer conventional and customised training programmes on-site and virtually.