Our Expertise
Phinique Technologies is a premier provider of engineering services for medical devices, pharmaceuticals, and healthcare products. We offer comprehensive solutions in product design, development, process optimization, verification and validation, prototyping, and testing. Our expertise extends to ensuring full QMS compliance with ISO 13485, FDA regulations, and EU MDR standards, delivering quality and regulatory assurance at every stage.
Our Solutions
We provide expert engineering services for medical devices, pharmaceuticals, and healthcare products, specializing in design, development, and process optimization.
Our capabilities cover the entire product lifecycle, from requirements and QMS compliance to production.
We turn ideas into reality, offering solutions from concept and design to prototyping, manufacturing, and assembly.
We deliver comprehensive end-to-end R&D and new product development solutions.
With extensive experience in R&D, design, and process development, we specialize in Class II and Class III medical devices.
Our team brings over 18 years of industry experience, ensuring excellence at every stage.
Our Product design portfolio
- Interventional
- Respiratory
- Endoscope
- Consumable and Surgical Products
- Innovation products
End to End Product Development
Understanding the end use requirements
Complete medical devices development support from clinical need to R&D. We have expertise in R&D , design and development and process development of medical devices, pharmaceutical equipment and devices.
Complete support for CAD
We are using various CAD tools for developing 3D models and engineering drawing, we can take care of managing your CAD needs, data management and engineering changes processes, our team is having expertise in geometric dimensioning and tolerancing, Tolerance stack up.
Medical device Standard compliance, FDA, EU MDR, QMS
Our team takes care of all standard compliance requirement for your product and managing those requirements. We take care of all ISO, IEC standards requirement and EU MDR, FDA regulations requirements. We create and maintain all regulatory documentation like Design control, FMEAs, Risk matrix, Part and product requirements, Design history file etc. for FDA and EU MDR.
Verification, Validation, Testing
Making and executing verification and validation plan for complete product, sub systems and parts, Risk analysis, FMEA’s , Risk management. Verification and validation of test methods through statistical methods – gauge R&R.
Specialized in Plastic & Metal product
We have expertise in plastic and sheet metal product design and development, we understand design and manufacturing needs and develop concepts accordingly.
Vendor development and management
Tooling development, co-ordination with vendors for getting parts developed and verified as per design requirements.
Prototyping and 3D printing
Complete support for Prototyping of designed products, functional and performance assessment of prototype products, understanding gap from prototyped product and implementing same for next revision if required. 3D printing, aluminum machining, sheet metal work for prototyping of plastic and metal parts
Process development, Fixture design and development
We Design and develop process to meet product requirements. We are expert in processes like Injection molding, Casting, Sheet metal, Welding, Polymer extrusions. Understanding test and process requirements, designing and developing fixtures as per these requirements.