Software documentation: Pass medical device approval fast and without hassle
We help you at minimal cost that your software documentation is 100% IEC 62304 and FDA compliant
Software documentation: Pass medical device approval fast and without hassle
We help you at minimal cost that your software documentation is 100% IEC 62304 and FDA compliant
What we can do for you
Within a few days our experienced experts will help you to get your "software documentation" IEC 62304 and FDA compliant including
- SOP Software development,
- software development plan,
- software requirements specification,
- software architecture and detailed design,
- software verification (e.g. code reviews, unit test, integration test as well as system test)
- software validation (for standalone software) and
- formal Software release
With these documents, you have everything you need to 100% safely pass audits and approvals.
How we will help you
We examine your situation and tell you exactly within two days what you have to do to document your software compliant with IEC 62304 and FDA requirements. We will help you for example
- by answering your questions (via e-mail and phone). We even do that for free! (more information here)
- by reviewing your documents and providing improvement suggestions (or directly implementing it)
- with templates, which we exemplary and specifically create for your product and then you "only" need to fill in the blanks
- by creating the complete software documentation for you
Interested? Here are your next steps:
Call us, write us an e-mail or fill out the contact form so that
- we understand your situation
- we both can sign a confidential agreement (if required)
- we create a customized quote just for you
- we will support you with our full competency
You can reach us
- by mail: info(at)johner-institute.com
- by phone in the US: +1 (301) 244 6335
- by filling out the contact form
We make sure that your software development documentation is
- compiled fast:
We are highly specialized on medical device software. We have- done it more than 100 times
- a set of proven templates and
- very experienced experts (computer scientists, programmers, regulatory affairs experts)
Faster help means for you no waste of time and faster sales.
- at minimal cost:
Not only that we work fast, but we also will empower you to to accomplish as you like as much work yourself. This immediately will minimize your cost and make you independent on consultants i.e. you will also save money also in a long run.
- 100% FDA and IEC 62304-compliant:
Our experts are not only auditors but also members of standards committee and know exactly, what is required. They make sure that you will avoid embarrassing complaints and time consuming, costly re-certifications. This enables you to pass approval without stress, delays and unnecessary costs.
- precise, concise, and practical
We are experienced software developers, software architects, and testers. We only will provide guidance that will help you to accelerate your software development and to turn your ideas faster into revenue-generating products.
- risk-free:
Because we have done more than one hundred software documentations, we precisely can estimate efforts and costs. This gives you an absolute safety in your planning. In addition, we also give you a 100% satisfaction guarantee. You pay nothing if you are not completely satisfied.
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