Our Services

Comprehensive solutions for medical device development and manufacturing from concept to commercialization.

The interior of a factory or assembly line is visible, with several workstations lined up neatly. Each station contains white plastic enclosures with electronic components inside, suggesting an electronic manufacturing or assembly process. Overhead lighting and blue tool boards are present, with some orange coiled cords hanging down.

Cleaning

We provide validated cleaning solutions for medical devices, ensuring removal of contaminants while maintaining material integrity. Our services comply with global regulatory standards, delivering safety, reliability, and quality assurance.

Validated Special Processes for medical devices, including Laser Marking, Passivation, and Surface Treatments, ensuring precision, durability, and compliance.
Your trusted partner in contract manufacturing, aligned with ISO 13485, FDA, and EU MDR for safe, high-quality devices..

Special Process

Sterile & Non-Sterile Packaging -Cleanroom

Sterile & Non-Sterile Packaging and Clean Room Assembly for medical devices, ensuring safety and reliability.

Fully compliant with ISO 13485, FDA, and EU MDR standards.

Sterilization

ETO, Gamma, and E-Beam Sterilization for medical devices, ensuring safety and efficacy.

Compliant with ISO, FDA, and EU MDR standards.

Our Projects

Explore our successful collaborations in medical device development.

Cleaning Validation for Implantable Devices

Executing validated cleaning studies to ensure removal of residues and contaminants from Class II implantable medical devices, in compliance with FDA,ASTM 3127 and ISO 19227 guidelines.

2D Barcode UDI Laser Marking for Surgical Devices

Implemented a 2D Barcode UDI Laser Marking program for surgical instruments and implants, ensuring permanent traceability, regulatory compliance, and developing a validated passivation (ASTM A967) method for stainless steel surfaces.

Sealing Process Characterization for Sterile Packaging

Transitioning from tray sealing to Tyvek® pouch sterilization, performing a sealing process characterization study to validate sterile barrier integrity, regulatory compliance, and product safety.This is aS per ISO 11607.

Medical Device Sterilization Modality Change and Packaging Development

Developing robust medical device packaging compatible with multiple sterilization methods (Gamma-ISO 11137, ETO- ISO 11135, E-beam -ISO 11137, H₂O₂- ISO 22441) to ensure device safety, sterility, and regulatory compliance

FAQs

What services do you offer?

We offer design, regulatory strategy, and manufacturing for medical devices.

What is your certification?

Our facilities are ISO 13485-certified, ensuring compliance and quality in all processes.

Do you provide packaging solutions?

Yes, we offer both sterile and non-sterile packaging solutions tailored to your product needs.

How do you ensure quality?

We adhere to strict quality standards and regulations throughout the development and manufacturing process.

What is your expertise?

We specialize in end-to-end solutions for bringing medical device innovations to market efficiently.

Can you handle special processes?

Yes, we develop and implement special processes tailored to meet specific medical device requirements.