ISO 13485 certification for an In Vitro device startup
An In Vitro device startup with no established QMS built a complete ISO 13485 quality system from the ground up.
Industry
Medical devices / IVD
Location
India
Services
Certifications & Quality
Category
Certifications & QMS
Certifications & QMSAn In Vitro device startup was seeking ISO 13485 certification but had no established QMS, lacked SOPs and documented procedures, and had a team unfamiliar with ISO requirements.
IVD Startup
Client Type
Medical devices / IVD
Product Category
India
Target Market
Challenges Faced
- No established Quality Management System.
- Lack of SOPs and documented procedures.
- Team unfamiliar with ISO requirements.
Our Approach
- Developed complete ISO 13485 documentation tailored to the organisation.
- Implemented SOPs and quality procedures across operations.
- Conducted internal audits and management reviews.
- Trained staff on the quality management system and ISO requirements.
A clear path, milestone by milestone
ISO 13485 documentation
SOPs & quality procedures
Internal audits & reviews
QMS training
What it meant for the client
Successful ISO 13485 certification.
Improved operational control and compliance.
Increased customer and regulatory confidence.
Key Results
Complete
QMS documentation
Implemented
SOPs & procedures
Trained
Quality team
Achieved
ISO 13485 cert
Every engagement is led by senior regulatory experts — with transparent milestones, complete documentation, and fixed-scope clarity from day one.
Ready to accelerate your regulatory journey?
Partner with Bio-State Consulting for end-to-end regulatory solutions and faster market access.