About us – Copy #3 – Shainy
Message from Our CEO
Dominic Sinibaldi
“HPC Medx has a strong customer focus with a dedicated team to help any size organization achieve their product and business goals. We look forward to speaking with you!”
Our Legacy - Serving Since 1913
Quality, Regulatory, and Compliance
At HPC MEDX, we are committed to being a high quality contract manufacturer to our clients. HPC MedX establish, implement, and maintain a quality system that meets the requirements of the referenced standards (QM, Section 2.0 Referenced Standards).In order to assure the quality of our products, we evaluate raw materials and develop manufacturing processes/procedures, inspection techniques, and packaging in conjunction with our clients.
- Our commitment to the health care field includes:
- • FDA registered as a Medical Device Contract Manufacturer
- •FDA registered as a Drug Facility, NDC # 51811
- •ISO 13485 Certified
- •ISO Certified Cleanrooms – Class 7 and Class 8
- •Total incorporation of cGMP
- •Foreign Manufacturer Accreditation by Japan (MHLW MO 169)
- •93/42/EEC Article 58 Exclusion
MedX has a consistent record of multiple audits with zero findings. Our quality results in 2023 include:
| Item | Goal | Actual Result |
|---|---|---|
|
Customer Satisfaction |
=/>95% |
100% |
|
Regulatory Compliance |
100% |
100% |
|
On-Time Delivery |
=/>95% |
100% |
|
Customer Returns |
<1% |
0% |
Why Choose Us
Customized Manufacturing:
From initial concept through production, we offer a suite of customizable services to handle projects of any size or complexity.
State-of-the-Art Facilities:
Our facilities include Class 7 and Class 8 cleanrooms and a 16,000 sq ft space designed for full assembly, minor fabrication, and distribution.
Advanced Technologies:
We utilize cutting-edge manufacturing technologies such as ultrasonic welding, thermal bonding, and computer-aided machining to ensure high-quality production.