“Regulatory, Development and Tech Transfer — from Switzerland to the Global Market”

Be Oriented is a Swiss company specializing in regulatory affairs, product development, and tech transfer for medical devices and solutions in aesthetic medicine, dermatology, and wellness. We support manufacturers, brand owners, and distributors from concept to commercialization, accelerating time-to-market with audit-ready documentation and processes compliant with the relevant authorities.

Our Mission

We bring safe, compliant, and high-performing products to market with an end-to-end approach: regulatory analysis, strategy, technical validation, registration, and post-market support. We measure each phase with KPIs and shared milestones, so you always know what we deliver and when.

What We Do

“from Concept to Submission: a Single Partner, Zero Friction.”

We cover the entire product lifecycle: MDR/IVDR (CEP/CER, PMS/PMCF, PSUR, UDI), QMS ISO 13485 (gap analysis, SOP, audit), design control and validations, multi-country market access (EU/UK, FDA 510(k)/De Novo, GCC/MENA, China/NMPA, India). We produce complete and updatable technical files.

Tech Transfer

Become a Manufacturer with Ready Dossiers: Faster than Starting from Scratch.

We provide structured dossiers and know-how to enable the distributor to assume the role of legal manufacturer. We offer handover, training, label/UDI adaptation, supplier qualification, and inspection support. Result: accelerated registrations and cross-market scalability.