Initiatives for Medical Device Manufacturing

Posted on by Scott Manea in ISO Standards, Medical Device Manufacturer, Process Validations 61 Comments

Traceability and Validation – Important Compliance Initiatives for Medical Device Manufacturing in 2017

 Some of you who read our Blog posts are quite well-versed in the ‘in’s and out’s’ of medical device manufacturing. It is a highly-regulated and quite diverse industry.

Most cutting-edge medical part manufacturers possess stringent process standards they employ in order to maintain a lean and measurable balance while adhering to stringent ISO 13485 Regulations, a Certification earned by C-Axis.

This Blog entry discusses 2 areas of Classification that certainly assist a company like C-Axis to remain at premium performance levels, while assisting our customers in experiencing greater amounts of success both now and into the future. 

Here’s how it works…

As a part of our ISO 13485 Registration, we must employ complete “traceability”. That means, from the point any material enters our facilities, it must be documented and that type of traceable notation and analysis is ongoing throughout the manufacturing process and, in some cases, all the way until it reaches the surgeon’s hands.

Here is how our Regulatory Entity explains an overall look at Traceability and Identification under our ISO 13485 Certification:

According to the ISO 13485 standard, the manufacturer is expected to establish the systematic identification of its business activities and process outputs throughout the material flow into categories and characters that are in accordance with predefined needs. The objective of the identification is to ensure that products at all levels and stages of the realization process will be identified regarding their production, change, and quality status. The identification shall also eliminate the risk of mixing products, parts, or materials from different origins or with different status. Products with incorrect identification could be incorrectly submitted to a process, delivered to the customer, or may initiate contamination of other products. Through the assignment of activities, means, measures, and identifiers throughout the material flow— such as codes, tags, or product serial numbers—they will be uniquely identified. The production elements that are to be identified include:

  • Raw materials, components, and parts
  • Materials used for the production
  • Lots or batches
  • Finished goods
  • Defective or returned goods

Any human entity wants to be validated, right? It’s in most of our DNA. A medical device manufacturer is no different…well, maybe just a little.

The act of “Validation” within medical device production goes fairly deep and is an integral component of the regulatory standards toward performing at maximum compliance.

A leading Compliance Entity defines “Process Validation” as this:

Process validation is an essential part of medical device manufacturing but doesn’t always receive the attention it deserves (and requires). The regulations provide the requirements (FDA QSR 820.75 and ISO 13485 7.5.2), but often manufacturers don’t completely understand them and don’t fully implement them. The consequences can be audit findings from a Notified Body or Inspectional Observations on an FDA 483.

Medical Device Manufacturer’s should validate processes when they do not verify everything the process produces. Process validation means knowing the range of process inputs that assure the process produces only conforming product.

At C-Axis, we choose to remain ISO13485 AND FDA Certified. Process Validation is an incredibly important part of what often separates a standard manufacturing company from a totally-dedicated medical device manufacturing serious player.

In the world of manufacturing medical devices, there are several “Classes” of device creation mainly based upon what and how the device will be used; we have outlined 2 important Classes here.  In a future blog entry, we will discuss how each of these Classes can affect the regulatory process…interesting information, right? We think so.