FDA, CE, and International Submissions—done right, first time.
510(k), De Novo, CE MDR, ISO 13485—expert help, faster approvals.
Clinical Studies, Usability, and International Submissions for MD & IVD—with proven resources across Europe and the U.S.
International clinical and usability studies for MD+IVD. We can help sponsors manage international studies, communicate more efficiently with research institutions, and stay compliant.
Help companies quickly prepare FDA/MDR/IVDR registration dossiers. Support fixes to issues raised by the Competent Authority or NB. Billing can be per project or hourly.
Provide various professional trainings and templates, such as EP series standards, clinical study management, registration process, and how to use AI to improve registration efficiency.
Assist sponsors with submissions and maintenance in countries such as India, South Korea, Singapore, Japan, Thailand, Indonesia, Vietnam, the Philippines, India, Malaysia, Australia, and New Zealand etc.
With proprietary, well‑maintained AI translation engine, we can generate bilingual documents (top–bottom or side‑by‑side). $1 per page; 1,000 pages ready in just 30 minutes—available instantly!
Provide QMS setup services, and support partner audits for companies targeting partners in U.S. and Europe.
We have extensive experiences in Clinical Studies, Usability Studies, FDA/CE preparations for MD and IVD. We can help you complete a full set of MDR/IVDR technical documentation within weeks.
As a certified RAPS member (RAC), we can also provide agile support across QMS, design and development documents, risk management files. Services range from brief phone consultations, targeted interpretations of specific standards or regulations, and drafting single documents/templates, to full project management—we tailor our support to your needs.
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