Medical device assembly requires a manufacturer that’s qualified, skilled and can follow the specifications for your specific product.
Whether it’s maintaining certification of a clean environment or conducting testing to ensure quality, you need to work with a manufacturing partner that you can trust.
In this post, we will review the most important qualification you should look for when choosing a manufacturer for medical device assembly and the key questions you should ask when vetting a new manufacturing partner.
Medical Device Assembly Manufacturing: The Basics
Medical device assembly includes the tasks of assembling high-quality products, often in a sterile, clean room setting. It can also include packaging tasks, such as labeling, folding, and sealing.
What to look for in a manufacturer
When selecting a manufacturer for your medical device assembly and packaging, you need a partner who is dedicated to ensuring the integrity of your product and packaging. Here are some considerations and questions you should ask:
- Customization – Is the manufacturer able to meet your specific needs? Do they offer options for packaging? Every medical device assembly project is unique, so it helps to work with a company that has the capabilities to meet your specific needs.
- Depth of Knowledge – Does the manufacturer have experience in the medical field? Do they have a reputation for excellence? In this industry, experience is important, so seek a manufacturer that has worked on a wide-range of projects.
Certifications – The medical device assembly process often requires a sterile environment. Ask potential manufacturers for their certifications and clean room capabilities.
- Quality Assurance – Quality assurance and following exact specifications are required in most medical assembly projects. It’s essential for the safety of your products and the people who will ultimately use them. Asking your manufacturer about their quality assurance process is a must, including information about inspection and validation.
- A Positive Work Environment – A positive work culture at your manufacturer might not seem important, but we believe being good to your workers helps ensure quality overtime. Whatever company you work with should have a positive work environment where employees feel valued and inspired to do their best work. It’s how you retain the best talent and gain valued, experienced employees.
Janco Inc.’s Medical Device Assembly and Packaging Process
Janco has nearly 60 years of experience in medical manufacturing projects. Our experienced team can work with you to customize your packaging design and ensure all requirements are met.
Our cleanroom capabilities include:
We also have numerous certifications and are an FDA registered facility. At Janco, we take quality assurance and safety seriously from the first day we receive a project to the moment it ships.
Searching for a partner for your medical device project?
Learn more about our capabilities in medical device assembly and packaging. Talk to us today.