Medical Device Manufacturers can benefit from Op-Smart
Medical devices range from syringes to pacemakers to certain hand sanitizers. Many companies specialize in niche markets that have unique requirements.
Can your organization relate to these concerns?
Entrance into European markets requires ISO 13485. It would be great to show auditors better process controls over what you have now. When auditors test your traceability by going through old paperwork, you worry about careless typos drawing their attention.
Op-Smart’s automated data collection and business intelligence analytics make process monitoring and control virtually effortless. Electronic data entry by operators (when automated collection isn’t optimal) significantly reduces input errors. Intelligent backflushing (for materials with a single lot in stock) frees up operator attention to focus on maintaining high quality and efficient production.
Paperless seems great in theory but we have a lot of paperwork. Our paper-based system hasn’t failed us yet in audits. Is it even worth establishing compliance with the FDA’s Title 21 CFR Part 11 for electronic record keeping and signatures?
Every situation is unique but gradual going .. Pilot programs allow you to develop trust in our system with an overall to your current business procedures. The employees in the early pilot programs also often become valuable teachers/advocates within your organization. Our experience with a range of companies can help us guide you down a manageable path toward paperless/automated data collection.
We are doing fine without automated data collection. Why burden ourselves?
Simple automated data collection can begin independent of employee training on Op-Smart. This information will be invaluable for establishing baselines and viewing historical trends when you do feel it’s time to look at them. Don’t lag behind your competition in implementing data collection and process control. No one ever regretted knowing too much about their process.
Some challenges faced by medical device manufacturers: