We’ve shared the importance of having an NPI, or New Product Introduction and Development Division, when integrating your technology to a Contract Manufacturer–you can read about that here. However, for this blog post, we’re going to focus on how the critical steps taken during the on-boarding phase within a NPI group will drive the success of Medical Device projects down the road.
When a Medical Device Company first initiates with PEKO, we’ll determine whether they’re an established medical device company introducing a new product, or if they’re a start-up company introducing a new product. It’s important to segment startups and established corporations because startups have specific needs for their proper path to market. PEKO proudly works with both types of organizations, yet we stay aware of the specific needs for start-ups’ proper path to market. This allows us to be confident that we’re providing companies with the proper tools for their success in the market. Let’s break down what we mean by this in a more granular sense.
Start-ups require quite a bit more guidance so we can be confident in the company’s success down the road. Much of the guidance PEKO offers involves educating and advising our start-up customers due to the strict regulations and guidelines that are set forth for Medical Devices.
1. Quality Management System
The Quality Management System doesn’t necessarily outline the functionality of the new technology but has everything to do with how the company is managed and how it runs. In the past, PEKO has assisted start-up companies with finding consultants so we could be confident they had everything in order throughout their company in a management sense. We care about the success of the companies who come to PEKO for manufacturing, and since we have experience working in the medical industry, we understand what critical steps must be taken in order to meet regulatory requirements.
2. Quality Engineer Assignation
3. Product Labeling
4. Documentation (DHR & DMR)
5. ECR (Engineering Change Request)
6. FMEA (Failure Mode Effects Analysis)
7. Regulatory Testing for End Result
- Electrical Safety
- Shock Hazards
- Power Surges
Manufacturing Medical Devices is a tedious process that involves critical steps to ensure both safety of a product as well as its success in the marketplace. If you’re looking for a Contract Manufacturer to help your company succeed, make sure they have experience in the Medical Industry so you can be confident in their ability to help bring you through this tedious process.
If you are interested in outsourcing your Medical Device manufacturing to a Contract Manufacturer, check out our FREE checklist to help you get started!