Can my medical device be produced by a manufacturer that is not ISO 13485 certified?

No ISO 13485 certified manufacturer

You want to produce a medical device. So, you decide to hire a contractor to do that for you.  And then the following questions come up:
How important is to hire an ISO 13485 certified manufacturer that will handle your contract manufacturing needs?
Can your medical device be produced by a contractor that is not certified?
Is it needed at all, is it really required?

On all these questions we will try to answer in this article.

Do you remember your struggle?

It’s very likely that your company is already ISO 13485 certified since you are in that industry. And you probably still remember the effort that you have put into maintaining a certification – the audits, the surveillance meetings, the documentation, etc. If you decided to outsource your medical device production, then you probably expect nothing less from the manufacturer.

It’s good to be ISO 13485 certified

Things like the traceability, design verification, materials validation, supplier controls, risk assessments, and other benefits are a crucial part of an operation in ISO certified company. And if your outsourced manufacturer is certified as well, then, you are on the same page, by following the same standards and regulations, therefore struggle has fallen down to a minimum. In other words, that means ISO 13485 certified manufacturer can meet your needs without the additional controls and traceability that accompany the ISO 13485 contract manufacturing certification process.

To point out what is important here. The point is that your certified manufacturer will focus on safety and can cover your companies back in case of an issue. More precisely, the emphasis is on handling risk – on foreseeing and resolving problems before they occur.

It’s a matter of choice

But what if not? What if your chosen manufacturer is not ISO13485 certified?

Why? Because it does not have to be certified. Yes, it’s a matter of choice.

What does that mean for you? It means your company will need lots of records to verify compliance with regulated processes. Simpler said, you will have to make sure to validate contractors manufacturing process, so their own final product can be validated. A manufacturer’s records must meet strict medical requirements.

Some companies go a step further in the validation process. They audit their critical component suppliers annually to make sure they meet the contractor’s testing and inspection standards.

So, the conclusion is the following: it’s manageable but it will require a lot of additional controls by the contractor in order to fulfill standard requirements. In the end, it’s your responsibility in front of auditors, inspectors, customers, etc.

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2 replies to “Can my medical device be produced by a manufacturer that is not ISO 13485 certified?”

  1. Margaret A. says:

    Interesting article. Our medical device is manufactured by ISO 9001 certified. Before we decided to go with them, there is a lot of inside struggles should we select them or not. We even heard that is the requirement that medical devices are produced by the company that is ISO 13485 certified.

  2. Simon V. says:

    OK, I just realized that this articles are connected, in sense, they have some order because I just got the answer to my question from the previous article. Maybe you guys, maybe put numbers in front of each title.

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