OEM / Third-Party Manufacturing
OEM & Contract Manufacturing Services
SPG Medisafe Private Limited provides end-to-end OEM and contract manufacturing services for medical devices, with a core focus on sterile disposable products. Our manufacturing operations are structured to support design transfer, pilot production, scale-up, and serial manufacturing, while maintaining strict compliance with applicable medical device quality and regulatory requirements.
Manufacturing Scope
We manufacture medical devices and consumables across multiple therapeutic areas, including:
Urology
Gastroenterology
Women’s Healthcare
Interventional Procedures
General Surgery
Our processes are optimized for single-use, patient-contact devices, requiring high consistency, controlled environments, and validated sterilization compatibility.
Manufacturing Infrastructure & Controls
- Cleanroom-based assembly areas designed for controlled particulate and microbial environments
- Dedicated assembly lines with process-defined workstations
- Validated ETO sterilization–compatible manufacturing and packaging systems
- Incoming material inspection, in-process controls, and final release inspections
- Batch-level traceability covering raw materials, components, and finished goods
Quality Management System
SPG Medisafe operates under a structured Quality Management System (QMS) aligned with medical device manufacturing best practices. Key elements include:
- Documented SOPs and work instructions
- Process validation and risk management protocols
- Change control and deviation management
- Supplier qualification and monitoring
- Device History Records (DHR) and batch documentation
Quality assurance activities are integrated into production to ensure product safety, performance consistency, and regulatory readiness.
Design Transfer & OEM Support
We support OEM partners through structured design transfer and processes, including:
- Design review and manufacturability assessment
- Process mapping and tooling/fixture development
- Pilot batches and process validation runs
- Packaging validation support for sterile devices
- Scale-up planning for commercial production
Our engineering and quality teams work closely with OEM clients to ensure smooth transition from development to routine manufacturing.
Sterilization & Packaging Readiness
All applicable products are manufactured using ETO sterilization-compatible materials and processes. Packaging systems are designed to maintain sterility, product integrity, and shelf life, with validation support available as per OEM and regulatory requirements.
Scalability & Capacity Expansion
SPG Medisafe is continuously investing in:
- Advanced assembly and automation equipment
- Expanded cleanroom capacity
- Increased production throughput
- Export-oriented manufacturing readiness
This allows OEM partners to scale production efficiently without compromising quality or compliance.
Confidentiality & Partnership Approach
We operate with strict confidentiality protocols and protection measures. Our OEM engagement model is built on long-term collaboration, transparency, and reliability, making SPG Medisafe a trusted manufacturing partner for both Indian and global medical device brands.