Laser marking and engraving of medical devices
Marking medical devices can be challenging for medical device manufacturers. Identification tasks become increasingly demanding and the industry's regulations are getting stricter, such as currently shown by the FDA's (Food and Drug Association) UDI (Unique Device Identification) directive.
However, manufacturers of marking systems and identification solutions take up the various challenges and multifaceted requirements and develop reliable solutions for medical device marking. Solutions that not only ensure the proper marking of all medical products but are also capable of improving medical device producers' process reliability and efficiency.
HELP is a holistic vision-assisted laser marking process that offers part and masks validation prior to and right after marking. HELP helps to avoid marking errors and is capable of validating laser contents right after marking. This is particularly important for users with strict quality and code integrity requirements.
HELP in three stages:
Laser marking with validation prior and right after marking eliminates potential marking errors.
1. Pre-mark verification
- Part validation: Validates correct part and prevents marking of wrong or defective parts.
- Pre-mark verification: Confirms that only unmarked parts are being processed.
- Mark alignment: Aligns the mark relative to the position of the part.
2. Laser marking (product identification)
3. Post-mark verification
- Mark verification: Validates that marks have been placed correctly (positioning, alignment, size).
- Optical Character Verification (OCV): Validates that every character marked by the laser matches the expected content.
- 2D code validation and code reading: Reads the contents of 1D and 2D codes (Datamatrix, e.g. ECC 200, GS1; QR) and compares the results to the expected content. A classification of the code into quality classes is possible.
The M-Series represents FOBA's next-generation of laser marking machines. The M-Series laser workstations process small, large and geometrically complex workpieces as well as batches and small series precisely and efficiently. The M-Series is available in two housing sizes (M2000 and M3000), and three models for each size (B: with work table, R: with a rotary table, P: with X/Y/Z axis).
Your product benefits
- Precision and process reliability: highly rigid workstation (polymer concrete), intelligent imaging technology
- Flexibility: integration into customer processes, various laser systems available, accessories and options for optimal customization
- Economy: small footprint, optimal machine accessibility, air-cooled laser systems
- Ergonomics: height-adjustable workstation for standing/seated work, individual adaptation to user's needs