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.

Medical Manufacturing Process

Posted on by Scott Manea in 3D Printing, ISO Standards, Medical Device, Medical Device Manufacturer, Prototype Development 32 Comments

The Single Most Important Part of the

Medical Manufacturing Production Process?

Especially When Considering the Extremely Detailed and Highly Precise World of Medical Device Manufacturing.

 How does a medical device manufacturing company receive the information to make valid decisions regarding how to ultimately manufacture any detailed medical device part?

And, before considering the actual process of medical manufacturing, that manufacturer must maintain a quality-efficiency compliant with stringent ISO standards; they must take into consideration the budget requirements, the delivery schedules and every step of the manufacturing process in order to perform the all-important “Design for Manufacturability” studies.

For some, this “up-front work” just to get a part set-up correctly, in the initial phases of the production process, can be a challenging task.

That’s why, in any “best practices” manufacturing arena, to set-up and integrate a dedicated department which is solely responsible for taking a drawing and creating something that can be measured (for all the above requirements) is absolutely essential.

Welcome to Prototyping at C-Axis

Prototyping has changed dramatically over recent years. Staying on the cutting-edge has made C-Axis a leader by utilizing strict prototyping standards; it has continued to maintain itself as an integral part of a continuing success-track for the company, to the benefit of every one of our medical device customers.

Within the prototyping stage, we are basically measuring everything and that does not only concern the actual size of any part!

We are measuring for compliance regarding how the part will be used, does it fit the desired requirements set by the customer, are there better ways to conduct the process not only to improve the part’s integrity, but to save time in the process to meet or exceed delivery deadlines, which can ultimately save cost.

Might there be a better material choice to use over what may have been initially specked; and a thorough, solid, deep analysis of the basic ingredients for design effectiveness.

Most everything and anything imaginable are questioned in the prototyping phase.

By the time the prototype becomes the model for how the final parts will be produced, it’s proven worth is beyond measure.

Without having those first parts to scrutinize, not much can be determined in order to solve any issue or potential problem – up-front; as one major goal of the prototype-process is to help eliminate surprises down the road. Prototyping can do that.

Many medical device manufacturing companies are utilizing 3D Printing as an important, integrated prototyping tool. C-Axis is no different. 3D Printing is, in itself, a constantly changing medium.

Having some of the best product designer’s on-staff also helps, along with cutting-edge CAD/CAM software to assist in uncovering optional production variables, potential problems and barriers. It is all a part of a truly defined and diverse prototyping department within a forward-thinking, medical device contract manufacturer.

Thanks for visiting the C-Axis Web Blog. Watch for another Blog Installment next month, the subject will be all about our incredible medical device production facility in Puerto Rico. “Te veo el mes que viene!”