Startups. A bigger challenge, a smaller tool stack.
Startups developing their first medical device face a bigger challenge. Quality and regulatory work (QARA) is often siloed, or the founder carries the burden.
Pain points
What gets in the way.
- There are no tools made specifically for MedTech startups.
- Too many tools lead to fragmented data and growing costs.
- Shared drives and access control look cheap, but they bring long maintenance and validation times that slow the work down.
- Training a new employee across all of it is hard.
The usual workaround stack
- Requirements
- A separate system
- Process documents
- Shared drives
- E-signatures
- A third-party platform
- Technical documents
- Stand-alone files
- Change control
- Digital paper
- Impact analysis
- Done by hand
- Document numbers and registers
- Spreadsheets
How OPRA Flow helps
One platform, built for this stage.
Compliance is possible this way, but it comes at a high cost. OPRA Flow reduces the tool stack and grows with you: data and process on the same platform, fully validated and kept validated, with simple interfaces that never make you feel like a fool with a tool. Everything a startup needs, without chasing new tools.
- OPRA Events
- Handle any quality event, all in one place.
- OPRA Train
- Makes quality and regulatory training fun, with quizzes and games that spread process knowledge across the whole team.
- OPRA Regs*
- Automates FDA submissions and takes the manual hours out of eSTAR applications.
- OPRA Supply*
- Run supplier management fully digitally.
- OPRA Plan*
- Purpose-built project management for MedTech companies.
- OPRA AI
- Makes all of it intuitive, powers your creativity and removes the mundane work.
OPRA Regs*
FDA submissions, automated. Hundreds of manual hours saved.
OPRA Regs automates FDA submissions and takes the manual work and anxiety out of filling in eSTAR applications.
* The entire work can be done in OPRA Docs with OPRA AI. Modules marked * are purpose-built interfaces that make the work easier than current standards.
Where to begin
Start small. Grow on the same platform.
- Begin with
- OPRA Docs, OPRA Events and OPRA Train, with the OPRA AI layer
- Grow into
- OPRA Regs*
Other segments