Behrad Royesh Royan
Quality Management
Regulatory Compliance
Product Validation
Continuous Improvement
ISO 13485
ISO 13485 is the internationally recognized standard for quality management systems specifically designed for medical device manufacturers.
RADA applies ISO 13485 throughout every operational process, including:
- Product Design & Development
- Manufacturing Control
- Supplier Qualification
- Process Validation
- Product Traceability
- Complaint Handling
- Corrective & Preventive Actions (CAPA)
Compliance with ISO 13485 demonstrates our commitment to consistently delivering safe, reliable, and effective medical devices.
EN ISO 14971
Patient safety begins with proactive risk management.
EN ISO 14971 establishes a structured framework for identifying, evaluating, controlling, and continuously monitoring potential risks throughout the entire medical device lifecycle.
Risk management activities include:
- Design Risk Analysis
- Manufacturing Risk Assessment
- Clinical Risk Evaluation
- Residual Risk Monitoring
- Post-Market Risk Review
EN ISO 10993
Medical devices intended for contact with biological tissues must demonstrate proven biocompatibility.
EN ISO 10993 provides internationally accepted methods for evaluating biological safety and confirming that materials do not produce unacceptable biological responses.
Testing includes:
• Cytotoxicity
• Sensitization
• Irritation
• Material Compatibility
• Biological Safety Evaluation
EN ISO 11607
Sterile packaging is critical for maintaining product integrity until the moment of clinical use.
EN ISO 11607 specifies requirements for:
• Sterile Barrier Systems
• Packaging Validation
• Seal Strength
• Transportation Testing
• Shelf-Life Validation
These requirements help ensure products remain sterile during storage and transportation.
EN ISO 15223
EN ISO 15223 standardizes internationally recognized symbols used on medical device labels, packaging, and instructions for use.
Standardized labeling improves communication, reduces user error, and supports global regulatory compliance.
ISO 14644
Manufacturing fertility medical devices requires highly controlled environments.
RADA's cleanroom facilities comply with ISO 14644 requirements by controlling:
• Airborne Particle Levels
• Temperature
• Humidity
• Air Pressure
• Environmental Cleanliness
Controlled production environments significantly reduce contamination risks while ensuring consistent product quality.
INSO 3001
INSO 3001 defines national technical and quality requirements for medical devices.
Compliance demonstrates conformity with recognized national regulations while supporting safe manufacturing practices and product reliability.
Ministry of Health & Medical Education (MOHME)
RADA products receive regulatory approval from the Iranian Ministry of Health and Medical Education after evaluation of technical documentation, manufacturing quality systems, safety data, and product performance.
These approvals confirm compliance with applicable national medical device regulations.
Behrad Royesh Royan Certification
RADA collaborates with leading reproductive medicine institutions to validate product suitability for IVF laboratories and assisted reproductive technologies.
Independent evaluation provides additional confidence in product performance within fertility clinics.
Raw Material
Inspection
In-Process
Monitoring
Final Product
Inspection
Packaging
Verification
Sterility
Validation
Batch Release
Authorization
HSSA
Successful HSSA results demonstrate that products are suitable for reproductive laboratory environments where preserving sperm function is essential.
MEA
This assay confirms that embryo culture conditions support healthy embryo development and verifies that products are free from embryo-toxic substances.
PMCF
Post-Market Clinical Follow-Up (PMCF) is an ongoing process of collecting and evaluating clinical performance data from real-world product use.
