The term “Medical Device,” is a broad term that can have a few different meanings. Depending on how the device is utilized, there are different classifications to determine quality assurance that is associated with the device’s manufacturing. Classifications of Medical Devices refer to Class I, Class II, and Class III which differentiate the level of risk associated with the device as well as the level of regulatory controls required during manufacturing. We offer various manufacturing services, but PEKO does not produce medical devices as the manufacturer that enter directly into the stream of commerce.
Regardless of their classification, Medical Devices have touched every person’s life in one way or another. And whether or not they have specifically saved our own lives, it’s safe to assume they have saved the life of someone we love. This is how important our company treats the manufacturing of Medical Devices and this sentiment is felt through each and every person who works on our custom medical equipment projects within our organization.
PEKO helps OEMs manufacture the newest medical technology and equipment, such as imaging, diagnostics, and assessment devices, utilizing decades of experience in medical equipment contract manufacturing. Contact PEKO today if your new medical equipment falls under categories like diagnostics, chromatography, mass spectrometry, purification, fluids and gas analysis, laboratory automation, molecular spectroscopy, MRI & CT imaging, and more. Learn how PEKO can help you with its suite of medical equipment contract manufacturing services.
Trying to figure out how your company will make your medical product can be a seamless process if you work with a qualified Contract Manufacturer. In this free guide, we offer tips on what to look for when you begin your search for a contract manufacturer to be the right fit for you and your company.
From product development to manufacturing, PEKO has been integral for leading OEMs in the Medical Industry. With a commitment to the understanding of quality system requirements, good manufacturing practices (GMP), and CFR 21, PEKO has been able to successfully produce medical products on behalf of our customers. A well-defined and disciplined quality system ensures traceability and compliance. The level of complexity involved in such products is seamlessly integrated into PEKO’s internal systems. Medical OEMs continue to enjoy value from the engineering and manufacturing expertise at PEKO.
If you’re in the Medical, Healthcare, or Life Sciences Industries, take advantage of the in-house capabilities PEKO has to offer. With our extensive service offerings, we’re ready to handle the complete management of your technology so that you can go back to focusing on what’s important in your business: research and development.
As a full-service medical equipment contract manufacturing company, we are fully prepared to take over the management of your project. When your company has spent its resources on the research and development of your technology, PEKO is ready to handle the manufacturing side of things.
Our in-house capabilities are as follows:
We want to make sure our customers will be successful once their medical device hits our production floor. In order to ensure success, we bring our Healthcare customers through our New Product Introduction and Development Department (NPI) where our staff and our customer’s staff both work congruently as we perfect prototype builds. In this phase, our dedicated engineers work to vet technology in an effort to verify to which degree the equipment works. It is during this stage that we work to perfect BOMs and manufacturing packages. Once we feel confident enough with both the technology and the manufacturing packages, then we are ready to send everything to our production department.
While projects are still in the NPI phase, our Program Planners, Upper Management and Quality Assurance teams work alongside our customers to outline realistic and obtainable goals. Once we understand where our customers envision their equipment and businesses to be in the future, we strategically plan out medical manufacturing and production plans to mitigate risk and ensure the success of our customers based on their goals.
Part of ensuring the success of our customers begins with our prototype builds. During this stage, the medical device prototype utilizes our engineering services heavily before we bring the project to our production team. Since Life Sciences customers come to PEKO at different stages of development, the ones who are early on in our development cycle receive the utmost care in driving their product into its next generation.
During this stage, cost-down opportunities are tackled as we work to fine-tune the device’s technology and functionality. Our engineers are dedicated to assessing and analyzing any potential risks during this phase so that we can be confident projects will be successful when they are transitioned over to our production team. PEKO routinely assembles a cross-functional team built to perform comprehensive risk assessments to develop strategies and identify opportunities to mitigate those risks in order to protect both the customer and the product end user.
To view some examples of custom medical equipment and machinery PEKO manufactured utilizing our NPI department’s full capabilities, please view our case studies below:
The key to a successful life cycle of a medical equipment is partnering with a manufacturer that has the right resources and experience. A great medical equipment contract manufacturer can bring a your device through the entire commercialization phase, beginning with prototype builds. PEKO has helped countless Medical OEMs through this tedious process.
The life cycle of any manufactured product is more of a feedback loop that provides improvements where needed. This is especially true when it comes to medical manufacturing. While we outline what the life cycle generally looks like below, know that developing and manufacturing medical equipment is a continuing process that evolves from initial plans.
Integrating Medical Equipment and Devices into our Assembly department is a process that we emphasize with very serious importance. Any project we work on that falls within the Medical Industry is provided with special importance to ensure a pristine quality accepted product is produced within our facilities. PEKO understands the necessity of introducing a medical product to the public that will perform as intended and is a reliable and safe choice for the community it serves.
Prior to accepting projects for our assembly department, PEKO first brings a project through our initial onboarding process. It is in this proprietary process that our NPI engineers review a build’s CAD files, quality requirements, and BoMs for accuracy. After we have completed successful builds through our NPI department, have vetted to which degree the technology functions, mitigated risk, and assessed for cost-down opportunities we then establish transition plans to integrate the project into production.
During our transition process into production, clear and concise work instructions are established. Assemblers are also trained on the methods and processes necessary to complete successful and qualifying medical builds. Developing detailed work instructions and training our assembly staff reduces the potential of assembling a product that fails to meet our customer’s expectations. Building a qualified assembly team and reproducing the same validated medical manufacturing methods on each lot supports PEKO’s “frozen process” approach.
Once customer projects are transitioned over to our full-scale assembly division, the floor has already been organized to ensure successful builds for our medical equipment. Our assembly floor managers utilize 5S to keep the workplace organized and clean, with defined processes to ensure each medical assembly adheres to the strict quality guidelines that are needed to ensure the safety of the product. When new customers arrive at PEKO, our floor managers make sure to include participation from our assembly workforce so that an inclusive, assembly process can be established for a successful program and high-quality products.
PEKO’s assembly floor managers always look for ways to improve our overall assembly process. By introducing new tools or assembly methods, and eliminating waste we are able to continually improve our efficiency. This can be accomplished through routine quality checks throughout each process which is especially important when it comes to assembling equipment that is used for the Medical Industry. PEKO’s Six Sigma Black Belts routinely use Lean practices to promote continuous improvement initiatives.
If you’re ready to disrupt the Medical Industry with your new machinery, come to PEKO! We work in tandem with you to ensure your success. When it comes to medical equipment contract manufacturing, we understand the importance of treating your product with care, every step of the way.
Many of the medical companies who work with PEKO take advantage of the newly allocated R&D for their business. When you’re looking to manufacture a high-level machine for the Medical Industry, only certain companies are equipped to handle such specialized equipment. For high-level jobs, like those in the Medical Industry, there’s only a certain number of businesses that are equipped to handle such specialized tasks. It wouldn’t make sense to handle dozens of small-sized fab shops when there’s too much at stake, rather work with a company that can offer you complete support over your entire project.
When it comes to pleasing your investors and stakeholders, make sure you choose a medical equipment contract manufacturing company with a sound infrastructure in place. Your investors and stakeholders are going to want to know that you’re medical machinery have the proper support when it comes time for production. Those who have worked in the Manufacturing Industry understand that problems can arise out of nowhere, which is why it is imperative to find a company that has the ability to mitigate such risks and have sound processes in place to remove any possibilities of bottle-necking.
When start-ups and smaller medical companies outsource their manufacturing to PEKO, the investors and stakeholders of these companies can rest assured knowing that PEKO has decades of experience to back their success. This is because PEKO has the credibility to handle the management of your project, leaving your resources to focus on the research and development part of your business. We support our customers at PEKO, through our many departments. From our engineering team in our NPI department, who help turn your technology into a reality, all the way through our supply chain, who manage the flow of materials, so you don’t have to worry about managing a whole list of suppliers.
Customers who engage with PEKO also rely on our company’s stability since we have been in the manufacturing business for over 50 years. Having decades of experience has allowed us to provide informed decisions to our customers as we help manage their medical manufacturing within our facilities.
PEKO is proud to be ISO 13485 certified since 2009. With over ten years of experience with this certification, we are confident to assist our customers manage their Medical Device Manufacturing.
When PEKO’s Senior Management Team decided to pursue our certification it was a decision that was based on a thorough review of the responsibility that comes with providing products that can have a profound effect on the quality of a person’s life. PEKO has been up to that task since obtaining our certification and we have been able to provide products that have the technology to save people’s lives. That responsibility led us to establish a steadfast commitment to provide our customers with quality products and the foundation of our commitment is reinforced by our continued implementation of ISO 13485 and our ability to understand and adhere to the applicable regulatory requirements.
According to ISO 13485:2016, all processes, procedures, and records must be clearly documented. Because of this, PEKO understands the importance of maintaining documentation that traces the historical records for each project. Medical Industry OEMs who engage with PEKO’s full-service offering, can rely on having access to our clear documentation if they need to review a process, at any time. Since this provides and requires us to provide our OEMs with great customer satisfaction, our customers rely on us for years of continued support.
PEKO establishes a training and competency review program to ensure that not only are the personnel that produces medical products trained but also continually review their competence and assess their need for continued education. The assembly of medical products can be very complex and not all employees share the same level of competence and training. In order to effectively assign responsibilities based on the employee’s level of training and competence our Supervisory staff maintains a matrix of qualified employees and the operations that they are authorized to perform. Only individuals who have proven they can produce a product that meets the established requirements are authorized to perform those activities. The matrix is periodically reviewed so the supervisor can identify opportunities for employees to learn new techniques and cross-train on multiple product lines.
When it comes to contract manufacturing for companies within the Medical Industry, PEKO leverages its vigorous quality system to check the various parts used in a medical machine throughout the various stages of manufacturing. Coupled with our quality system, PEKO maintains clear documentation to ensure our quality claims.
Since we are following GMP, our quality department verifies that we are following the IQ, OQ, PQ processes.
The first step for a successful validation is to ensure the equipment that is being used to produce medical products is installed correctly and working properly. Validating that the equipment used to produce medical products is safe and reliable provides confidence to the manufacturing functions that machine failure is less likely to happen. PEKO will also perform calibration of the machines to make sure they are performing as intended. The machine’s critical safety features are tested to make sure personnel that uses the equipment are safe and out of harm’s way if there is a machine failure. PEKO creates maintenance schedules in order to prevent the machine from failing or breaking down and causing product failures or disruption of manufacturing schedules. Only after the equipment is tested, challenged and evaluated can a proper analysis of the machining process be initiated.
After the equipment has been installed and deemed ready for use, PEKO will begin the Operational Qualification phase which is designed to determine if the machine will produce defined process parameters under all anticipated conditions. Part of this process is to ensure that a manufacturing process can be adjusted at various levels and still maintain a state of control. Typically, PEKO will perform statistical analysis of the process for optimization and establishment of process stability. This stage allows PEKO to determine if the process will consistently produce products that meet the established design or process parameters.
The last step for validation is the Performance Qualification phase. This stage allows PEKO to determine if the process will consistently produce products, under normal operating conditions, that meet the established design or process parameters. PEKO will monitor the process using statistical techniques to analyze process repeatability. PEKO’s team reviews the findings of the validation activities and will determine if the designed process and equipment will perform at a level that can consistently meet the manufacturing objectives.
Current Good Manufacturing Practices are essential to the success of any manufacturer of medical products. PEKO uses CGMP to assure that quality is built into our manufacturing processes. Through practices recommended and mandated by the Medical Industry PEKO is able to control our Quality Management System and processes to mitigate risks, prevent product failures and ultimately provide our customers and consumers with confidence in our ability to provide quality medical products. Procedures are developed by focusing on efficiency, compliance, loss prevention, and customer satisfaction in order to successfully meet our contractual obligations and remain a leader within the manufacturing community.