Bio-Standards
المقاييس الحيوية
Business Services · Riyadh
About
Bio-Standards is a Riyadh regulatory representative focused on medical device registration with SFDA for manufacturers based outside Saudi Arabia. It acts as authorised representative, prepares MDMA applications and technical files, and supports import and distribution licensing, UDI, vigilance and quality management system work.
Products & Services (22)
- Authorized representative
- Biocompatibility evaluation
- Clinical evaluation
- Clinical trial submission
- Ivd performance evaluation
- Logistics and supply chain compliance
- Medical device advertising license mdal
- Medical device ar licensing
- Medical device importation and distribution license
- Medical device marketing authorization mdma
- Medical device registration with SFDA
- Medical device udi
- Post-market surveillance
- Process validation
- Quality management system services
- Risk management
- Saudi market assessment
- Saudi vigilance system
- SFDA product classification system pcs
- Stability and shelf life
- Technical file preparation
- Usability engineering validation