ISO 13485:2016
Medical Device Quality Management
Quality-management framework supporting the development, manufacture and control of medical devices.
Structured Quality.
Documented Responsibility.
At SinaVita®, quality is built into how our products are developed and manufactured. All SinaVita® products are developed and manufactured by MIM Pharma AS in Norway within internationally recognized quality-management frameworks.
ISO-Certified Quality Management Systems
MIM Pharma AS operates under active and independently audited ISO certifications:
ISO 9001:2015
Quality Management System
Organization-wide framework for consistent processes, quality management and continual improvement.
ISO 22000:2018
Food Safety Management
Food-safety management framework supporting controlled processes for applicable food and dietary supplement products.
CE Marking & Regulatory Registration
Regulatory Compliance By Product Category
SinaVita® products are developed and manufactured according to the regulatory requirements applicable to each product category.
Medical-device components are CE-marked and documented in accordance with applicable EU MDR requirements, while dietary supplement products follow the applicable food-safety and regulatory framework.
EU Regulatory Framework
Developed Within Applicable EU Regulatory Frameworks
- Technical documentation
- Risk-management procedures
- Applicable post-market requirements
- Regulatory traceability
- Intended-use and labeling requirements
Requirements are applied according to the relevant product category and regulatory classification.
Manufacturing & Control
Controlled, Documented, Reproducible
- Structured quality-control procedures
- Defined manufacturing processes
- Controlled manufacturing environments
- Traceability systems
- Periodic internal and external audits
Supporting consistency, documentation and accountability throughout the product lifecycle.
What This Means For You
Structured Systems. Developed Within Defined Quality Frameworks
ISO 13485
Certified
ISO 9001
Certified
ISO 22000
Certified
CE-Marked
Applicable Medical Devices
Documentation & Verification
MIM Pharma AS maintains documented quality and compliance processes across the development and manufacture of SinaVita® products. Our ISO certifications are independently audited and subject to ongoing surveillance in accordance with the applicable certification requirements.