You inherit their gaps.
When a supplier skips a validation step or delivers an incomplete certificate, the finding lands in your audit and the delay lands in your project plan. Their problem becomes your problem.
"Suppliance" is the new supplier development platform by SIFo Medical: a training portal branded to your company, weekly live mentoring with an ISO 13485 Lead Auditor, and AI review of supplier documentation.
Most suppliers are excellent at making parts. Few of them know what ISO 13485, process validation or a complete first article submission actually require. So your team fills the gap. Again and again.
When a supplier skips a validation step or delivers an incomplete certificate, the finding lands in your audit and the delay lands in your project plan. Their problem becomes your problem.
Explaining sample sizes, TMV and documentation requirements to every new supplier eats hours your engineers should spend on your own products. And six months later, the next supplier asks the same questions.
Missing calibration records, wrong material certificates, incomplete dimensional reports. Every incomplete submission means another review loop, another email chain, another delayed release.
2 minutes, free, no commitment.
Join the WaitlistYou get a training portal in your company's branding. Your suppliers log in and work through proven courses on TMV, validation and MedTech documentation requirements at their own pace. What's in it for you: suppliers learn exactly what you need them to know, and your team never explains the basics again.
Once a week, your suppliers bring their real questions to a live online session with Simon Föger. Concrete answers on their actual projects, not theory. What's in it for you: supplier questions get expert answers without blocking your engineers, and problems surface before they reach your incoming inspection.
Supplier documentation gets an AI review against your requirements before it lands on your desk. Gaps, missing records and inconsistencies are flagged while the supplier can still fix them. What's in it for you: you review complete submissions instead of chasing incomplete ones, and releases stop waiting on paperwork.
What you get: early access before the official launch, and a direct say in what we build.
Suppliance is in the building phase right now, so tell us which features would help you most and we build the platform around them. One platform for supplier development: training, mentoring and document review, finally in one place.
Simon is a MedTech expert and ISO 13485 Lead Auditor with over 15 years qualifying, auditing and developing suppliers for medical device manufacturers, including high-risk and Class III devices. He built a GMP manufacturing site in Shenzhen from the ground up and knows exactly where suppliers struggle with MedTech requirements.
As a TÜV SÜD Academy trainer, he trains QA/RA professionals worldwide in validation and applied statistics. The courses inside Suppliance are the same material, made accessible for your suppliers.
Suppliance packages that experience into a platform: your suppliers get the training and the answers, you get the results.
You get compliant suppliers with minimal effort. Your suppliers get valuable MedTech know-how to understand what is absolutely required in medical device compliance.
You own the supplier releases and the audit answers. Suppliance gives you suppliers who understand the requirements and documentation that holds up when the auditor asks.
Your best machining shop has never heard of ISO 13485? Suppliance takes them from zero to your compliance level, without months of hand-holding by your team.
Ten suppliers you can manage by email. Fifty you can't. Suppliance makes supplier development repeatable, so growth stops multiplying your quality workload.
Join Waitlist
2 minutes. Free. Direct influence on what we build first.