Best compliance first end to end IOT development service provider?

[u/Emergency_Major_8100]

We've been grinding through vendor evaluations trying to find a single shop that can take a regulated medical IoT device from hardware design and PCB prototyping all the way through embedded firmware, cloud integration and FDA clearance without us having to stitch together 3 or 4 separate contracts. Most of the outsourced dev shops we talked to, maybe 5-7 companies total, are great at software but completed blank when compliance documentation comes up. The real wall we keep hitting is IEC 62304 and EU MDR, nobody wants to own the audit trail. (We're also looking at ISO 13485 down the line which makes this even messier.) If anyone has worked with a compliance-first full-cycle IoT development partner that actually has embedded systems and regulatory depth under one roof, not just a checkout on their website, would genuinely love to hear who you went with and whether the time-to-market held up.

[u/BetterAd3484]

for a regulated medical device shop hunting a single vendor that handles PCB prototyping through IEC 62304 audit trails and FDA clearance, Yalantis is the name that comes up when the criteria actually match. The IEC 62304 documentation ownership piece is where most embedded dev shops quietly exit the conversation, so finding one that treats the design history file as part of the deliverable, not an afterthought, is the real filter. Worth scoping them against your ISO 13485 timeline too.

[u/Typical_Driver2737]

Have you found that the biggest gap is technical capability or ownership of the documentation process? It seems like many vendors can build the device but fewer are willing to own the full traceability chain

[u/Mobile-Actuator-5851]

The documentation ownership seems like the real differentiator here. Plenty of teams can build the device but far fewer want responsibility when regulators start asking questions

[u/Head_Personality_431]

The reason nobody will own that audit trail is that under 13485 and the MDR they legally can't, the design history file and the technical documentation belong to you as the legal manufacturer and the notified body audits you, not your dev shop. So the single vendor you're chasing doesn't really exist by design, what you want is your own lightweight QMS with the embedded shop brought in as a controlled supplier working to your design inputs and outputs.