Medical device companies looking for a PCB design and assembly partner have many important factors to consider, all with the end user’s well-being at risk. Finding an experienced, ISO 13485 certified manufacturer is one of the most important.
In an industry where lives really do hang in the balance, medical device OEMs need to know they’re dealing with someone proven to meet the standards for ISO certification for medical devices. Working with a contractor that has ISO 13485 certification can help OEMs meet the standards of the U.S. Food & Drug Administration’s Quality System Regulation as well as Current Good Manufacturing Practices. But there's more to it than that.
What does ISO 13485 certification actually entail that makes it so reassuring? What can happen if the certification isn’t there?
ISO 9001 Vs. ISO 13485 Certified Manufacturer
You may be asking, if the issue is quality, isn’t ISO 9001 -- with its emphasis on continuous improvement and customer satisfaction -- enough? Not in the medical world.
If a contractor has ISO 13485 certification, it also has ISO 9001 certification. ISO 13485 basically adds another, critical layer the foundation that is ISO 9001.
A standard for quality management systems aimed specifically at medical devices, ISO 13485 focuses on safety and covering your butt in case of an issue. More specifically, the emphasis is on managing risk -- on foreseeing and fixing problems before they occur.
The standard ensures that safeguards are in places for medical manufacturers, including:
- Record keeping
- Device history records
- Regulatory requirements for documentation and records
- Product and process verification procedures are carried out on protocols specific to medical devices
- A contractor’s entire supply chain is re-evaluated
- Auditing occurs annually
In other words, ISO 13485 represents an exhaustive effort to make sure each component of a medical device meets the most rigorous safety standards.
In many cases, the electronics contract manufacturer (ECM) is ISO 13485 certified, but the OEM -- the customer ordering that PCB assembly — is not. OEMs are strictly regulated by the FDA and have to comply with Current Good Manufacturing Practices (CGMP), which focuses more on the finished product than the guts within.
The spirit of those same guidelines are baked into ISO 13485, so certified manufacturers have shown to auditors that they’ve applied CGMP, too. That’s yet another valuable layer of support behind a medical device manufacturer!
ISO 13485 Certification: a Critical Extra Layer
A manufacturer doesn’t have to be ISO 13485 certified to meet its standards. And it doesn’t have to be ISO 13485 certified to make and sell medical device components or the finished devices. But a medical device manufacturing certification tells everyone, regulators and customers included, that your electronic components have undergone an objective evaluation by a third party and met all the requirements for producing safe goods.
An electronics manufacturer can be part of a long supply chain and, with an ISO certification for medical devices on its side, assure customers that its part of the process is held to the highest standards.
Medical Device Contract Manufacturing Without ISO 13485
Such rigor is not mandatory -- you can legally release a product to the market without using a certified supplier. It’s up to you whether to add this layer of quality control.
So, what could go wrong if this “unnecessary” certification isn’t accomplished? What if a component manufacturer doesn’t have ISO 13485 certification and something goes amiss when the device is used in the emergency room?
Chances are the FDA will investigate the OEM. And that means the OEM will need lots of records to verify compliance with regulated processes. If the medical device contract manufacturer can say with confidence that all the necessary records are available, any OEM will sleep easier.
OEMs want validation of a contractor’s manufacturing processes as a way to help validate their own final products. A PCB manufacturer’s records must meet strict medical requirements.
Some contractors go a step farther in the validation process. They audit their critical component suppliers annually to make sure they meet the contractor’s testing and inspection standards. Working with such a contract manufacturer is a great way to reinforce the safety chain without lifting a finger.
ISO 13485 Benefits Summarized
Because of strict industry requirements, companies responsible for selling finished medical devices score some important benefits when using a ISO 13485 certified manufacturer, including:
- Thorough, clear understanding among all parties of the device’s end use, avoiding errors in design and manufacturing
- Risk analysis methods that are well-defined and effective to avoid expensive safety problems that appear after final production
- Focus on the end-user to ensure ease of use, safety, and effectiveness
- Audits to make contractors fully accountable for product quality and safety
The first question when an OEM courts an electronics or other medical device component manufacturer should be: “Are you ISO 13485 certified?” The answer carries a lot of weight.