PEKO Precision Products
ISO 13485 Contract Manufacturer of Complete Medical Systems & Equipment
PEKO Precision Products works with original equipment manufacturers (OEMs) to produce medical devices, diagnostic instruments and systems.
PEKO Precision Products is a vertically integrated contract manufacturer of Class I and Class II medical equipment, diagnostic instruments, and systems.
We help innovators in the medical industry bring groundbreaking developments to market in the areas of diagnostics, chromatography, mass spectrometry, purification, fluids and gas analysis, laboratory automation, molecular spectroscopy, magnetic resonance imaging (MRI), and computerised tomography (CT) imaging, among others.
When start-ups and smaller medical companies outsource their manufacturing to PEKO, the investors and stakeholders of these companies can rest assured that we have decades of experience to back their success. All our customers, including those in the medical industry, retain full ownership of their design’s intellectual property (IP) and this proprietary information is protected through secured assembly areas, cybersecurity protocols, and other precautions.
Qualified workforce for manufacturing operations
Because of the complexity of medical technology, PEKO Precision Products has established a training and competency review programme for its employees. The purpose of this programme is to ensure that employees are properly educated and trained in manufacturing medical products.
From this information, our management team can keep a matrix of qualified employees and the operations they are authorised to perform, allowing only the most qualified engineers and machinists to perform medical manufacturing processes and activities. The matrix is periodically reviewed so that management can identify opportunities for employees to learn new techniques and cross-train on multiple product lines.
In addition, PEKO’s Six Sigma Black Belts routinely use lean manufacturing practices to promote continuous improvement initiatives.
Regulatory compliance and quality assurance
PEKO Precision Products understands the need to introduce medical products that will perform as intended and are reliable and safe choices for the community they serve. Therefore, we are committed to providing customers with the highest-quality products possible.
The foundation of this commitment is reinforced by our continued implementation of ISO 13485 and our ability to understand and adhere to the applicable regulatory requirements. PEKO has been a proud ISO 13485-certified contract manufacturing partner for medical solutions since 2009.
Medical original equipment manufacturers (OEMs) who work with PEKO will have access to clear regulatory documentation that they can review at any time. Any medical project we work on is carried out with special attention to detail to ensure a high-quality product.
Current good manufacturing practice (cGMP) process validation
In addition to being ISO 13485-certified, PEKO Precision Products also complies with the US Food and Drug Administration’s (FDA) Code of Federal Regulations (CFR 21) and current good manufacturing practices (cGMP). These include installation, operational and performance qualifications.
We have processes in place to prove that your device design complies with good manufacturing practice (GMP) and ensure proper set-up, installation, operation, and performance.
We use cGMP to ensure that quality is built into the manufacturing processes of each medical manufacturing project. These practices allow us to control quality assurance and processes to mitigate risks, prevent product failures, and give our customers confidence in our ability to provide quality products.
These procedures are developed by focusing on efficiency, compliance, loss prevention and customer satisfaction to successfully meet our contractual obligations and remain a leader within the manufacturing community.
Medical industry experience
PEKO Precision Products partners with some of the most innovative medical start-ups and OEMs to provide complex solutions in a variety of medical industry sectors, including radio oncology, imaging, diagnostics, pharmaceutical dispensers, medical robots, surgical equipment, and biological storage.
In the past, we have successfully brought various medical technologies to market such as:
- MRI radiation scanning system
- Narcotic dispensing machine and inventory management system
- Physical therapy and rehabilitation technology devices
- 3D CT scanner and imaging equipment
Why choose PEKO?
PEKO Precision Products differs from traditional contract manufacturing and product development companies in four ways:
- Our extensive vertical integration allows us to manufacture critical to function components and most of the mechanical parts and subsystems on-site.
- Our uniquely experienced project management team is tailored to high volume production requirements or traditional ‘one-of-a-kind’ systems.
- Our product development team includes mechanical and electrical engineering and design capabilities.
- We have incorporated a robust method of providing quality at the component level, the subsystem assembly and the final integration phases of the equipment build, avoiding costly and time-consuming debug time at start-up and installation.
This strategy provides our customers with comprehensive medical manufacturing solutions.
Our engineering and manufacturing teams can work from customer computer-aided design (CAD) models, detailed drawings, or specifications. All finished builds are assembled, tested, and shipped from our facility in Rochester, New York, US.