OEM & Contract Manufacturing Services – SPG Medisafe

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.

Third-Party Manufacturing

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.