Quality Assurance
Regulatory Affairs
Quality Assurance &
Regulatory Support
BIOTEQ integrates quality assurance and regulatory support throughout medical device OEM manufacturing.
Our teams work with partners to address applicable quality-system, manufacturing, validation, documentation, and target-market requirements according to product scope and project responsibilities.
How We Support OEM Regulatory Requirements
BIOTEQ supports OEM customers throughout product development, production transfer, and commercial manufacturing with:
01
Quality planning and document control
02
Verification and validation support
03
Process and product inspection
04
Corrective & Preventive Action (CAPA)
05
Documentation compliance to client
06
Customer audit support
07
Certificate and facility-scope confirmation
08
End-to-End Product Traceability
09
Quality Control
10
Lot Records Control
11
Sterilization and packaging records control
12
Sterilization and packaging records
Regulatory pathways and documentation are evaluated according to the product, manufacturing facility, and intended market.
Quality Certificates & Regulatory Registrations
All our medical devices are designed and manufactured under an ISO 13485:2016-certified quality management system and applicable US QMSR requirements. Product-specific regulatory pathways and documentation are confirmed for each OEM program.
For more information, please contact us>>