If you are having trouble choosing the right medical equipment manufacturer in Toronto, we can help. The medical device manufacturing process and medical device contract manufacturers often go hand in hand; this is especially true when original equipment manufacturers are involved. Outsourcing is also common when original equipment manufacturers require aid in a particular area of expertise, and may include research and development design, casting, joining and molding.
Another reason why choosing the right medical equipment manufacturer in Toronto is so important to the original equipment manufacturers overall success is because custom tailored fabrication must be done by a connoisseur. Evidently, choosing a medical equipment manufacturer in Toronto is not an easy task, nor should it be taken lightly. Here, we provide you with the information required to make a sound decision so that doctors and patients can have the best medical devices available.
Certain Criteria Must be Met
By including certain criteria in the decision-making process an original equipment manufacturer will know that the medical equipment manufacturer that they selected was the correct choice. Certain criteria that should be taken into consideration include: cleanroom capabilities, delivery performance that is on schedule, quick and timely responsiveness and an ISO 13485 certification, with a focus on superlative quality. Below is a more detailed breakdown of the aforementioned criteria.
ISO 13485 Designation with Emphasis on Quality Focus
The quality system in question must be comprehensive and must include an ISO 13485 certification. Having these criteria met will make the contract manufacturer far more appealing to the original equipment manufacturer. For those who are unaware of what the ISO 13485 certification entails, it mandates that certain criteria for quality management systems are adhered to.
Furthermore, the organization that actually provides the affiliated medical services and devices must also meet regulatory and client requirements on a consistent basis. The organization in question may also be involved in any stage of the lifecycle of the medical device, regardless of how big the organization is or its type.
Risk mitigation plans and FDA compliance should also be enforced so that you know they have a focus on quality. In other words, you’ll know that a manufacturer that has the aforementioned accreditations has invested the money and time needed to manufacture a state of the art system that doesn’t compromise quality for profits. In fact, most such medical device manufacturers have their own protocols, systems and high standards for their own personnel, and usually don’t require any guidance form external entities in order to manufacture a premium grade medical device. In sum, when you are deciding on which company to go with remember that quality is the most important criteria, as the very lives of patients depends on their quality, speed and reliability.
Make Sure that Cleanroom Capabilities are Included
When choosing a medical device manufacturer you should select one that has cleanroom capabilities; this is because the chance of contamination is very low when the medical devices are made in a cleanroom. Such devices also tend to be of a much higher quality when compared to devices fabricated in non-cleanrooms, as the cleanroom personnel tend to have far more skill than other manufacturing employees. Cleanroom personnel also tend to be more diligent and meticulous when caring for medical devices through the entirety of the manufacturing process.
You can further narrow your search for the best manufacturer by opting to go with a manufacturer that provides ISO 13485 compliance, as well as ISO 14698 and ISO 14644 compliance for cleanrooms. Moreover, laminar-flow workstations that are class 100 must be used for medical devices that require very high levels of cleanliness. They must be used throughout the assembly and fabrication life cycle of the medical device. Furthermore, the cleanrooms in question must be rated at Class 10,000 at the very least.
The medical device contract manufacturer must provide a quality control system that is very robust, and they must showcase cleaning capacities for both components and medical devices. They must also follow all regulatory requirements, and operate gowning areas that are separate in order to lower the risk of contamination.
Their systems must also deliver nitrogen that is filtered, air that is clean and water that is pure. In sum, if the contract manufacturer doesn’t have a dedicated and expansive client and production team available in order to ensure the absolute best quality control for every project, they should be avoided at all costs.
Responsive and Timely Performance
Communication is key, and the relationship between the contract manufacturer and the equipment manufacturer must be superlative. For instance, you cannot wait for long periods of time for the contract manufacturer to respond, nor can you waste money while doing so. Check to see how responsive the potential contract manufacturer is in order to ascertain what you can expect from them on a daily basis.
You should also take the time to tour their facility, meet their quality control team and ask them any specific questions you may have. No questions, however uncomfortable or awkward, should be off limits. Moreover, any red flags that come up can help you narrow your search down even quicker.
Finally, the medical device manufacturer that you end up choosing should have an excellent track record regarding on-time delivery performance. For instance, if you need to stay on time and within budget at all times, their performance rate will matter greatly. Or, if you need to get medical devices out as soon as possible then you should choose a medical device manufacturer that offers product development that is rapid. In other words, the contract manufacturer’s capabilities must be properly matched to your specific needs.
If you would like more information on selecting the right medical equipment manufacturer in Toronto, please call Circuits Central at 1-888-821-7746 or visit our website.