The Certification Process for Laser Marking of Medical Devices

In detail, the book explains the entire process of laser marking of medical devices, from sending the product to the lab for inspection to obtaining the certificate. It covers the certification standards, the preparations of the materials, the technical review, and other critical steps.This will help companies clarify the core steps for laser marking certification, avoid common problems, quickly pass medical device compliance reviews, and ensure a smooth launch of their products.

Why are certifications necessary for laser marking of medical equipment?

Laser marking on medical devices is no simple matter of just putting a few words on a product. This is especially true of products that involve patient safety, such as surgical instruments and implants.The markers must be clear, corrosion resistant, and able to withstand sterilization and disinfection.If the labels were to fall off or become illegible, it might affect hospital management, or even lead to medical accidents.For this reason, regulatory agencies in various countries (such as Taiwan's NMPA and the US FDA) all take laser marking as a key item in their quality inspections.

Preparation for certification

Confirm the contents and location of the marking.

First, we hold a meeting with the R & D and production departments to clearly mark the content (such as model number, batch number, and UDI code) and marking location.Don't underestimate this step--a customer once had a label placed too close to a moving part, which rubbed the label off and resulted in lost information. The customer was forced to redesign the mold, wasting six months.

Material compatibility tests.

Medical instruments made of different materials (such as titanium alloy, stainless steel, and high-molecular materials) require vastly different laser parameters.It is recommended that a test sample be prepared in advance to check for cracks or discoloration.For example, in one case a laser beam was found to have caused a section of a bone plate to carbonize, creating a potential break point.

The most critical step in the process.

Prepare technical documents.

Don ’ t just focus on the test reports; put together a chain of stories that includes the parameters of the laser equipment, data from the verification of the marking process, and the results of long-term tests.The reviewers love to see a logical chain of evidence. For example, to prove that the markings on the disc will be readable for the 10 years of its warranty, they will run an accelerated aging test.

Choose a testing agency.

Prefer labs with CMA and CNAS certification.If a product is to be exported to many countries, it can be tested by an agency that will provide both FDA and CE certification.Last year one company was able to cut its inspection costs by 30 % by using this method.

Technical review--a guide to avoid the pitfalls.

They will be reviewed on the spot.

Auditors may suddenly visit the factory and demand to see the marking process.Remember to train your operators in advance to be sure that they can easily call up the marking programs for different products.A company was nearly cited for "non-conformance" after a parameter was misoperated.

Common problems in reform.

80 % of the returns are because the markings are not clear enough.I'll teach you a trick: use an alcohol swab to wipe the marked area 20 times, and then take a photo with your cell phone in macro mode.If you can still see each character clearly, you have passed the test.

Things to remember after getting your certificate.

Don't rush to celebrate when you receive your certificate. First check to see if the specifications on the certificate are the same as those of the actual product.One manufacturer got caught out: the certificate said the product was made of stainless steel, but they later added a titanium alloy model. The result was that the warehouse was sealed up.I recommend that a change management process be established, so that any adjustment to the production process requires a reassessment of the scope of certification.

Finally, a reminder: Some provinces and cities have now launched electronic license systems. Be sure to download and save your license.Last year, during the period of pandemic lockdowns, there were companies who missed out on bids because they had their paper certificates locked up in the office. That lesson should be learned.