Easy!

1. Download the free vendor qualification package and use it to approve toolval.com as a vendor, per your QMS.

2. Purchase the tools & versions you need validated. Ensure the intended use of the tool validation aligns with how you generally use it (if not, email hello@toolval.com and we can add it).

3. Download purchased tool validation summaries and implement into your QMS!

4. If required, a QMS audit is also available for purchase for read-only access to our QMS procedures.

Yes! We are compliant with 21 CFR 820, IEC 62304, and ISO 13485.

While our ISO 13485 certification by a NB is not complete yet, we have performed internal audits to ensure our procedures are compliant with the standard.

Many companies lack resources to perform in-depth tool validation, have burdensome procedures, gate-keepers that waste time, and sometimes lack a proper risk-based interpretation of FDA regulations and guidance. Conversely, consultants can require lengthy start-up meetings and opaque pricing. We want to allow medical device companies to focus on what they do best - medical device development. ToolVal.com allows medical device companies to purchase tool validations at a lower cost then in-house and consultants, that are immediately validated.

Evidence that the tool/version/configuration has been validated for a stated intended use in a compliant QMS, in the form of a Tool Validation Summary, which includes risks, requirements, and traceability. We don’t provide tool access.

We run our tests every month and add the test summary to the records available. After purchase, you can access them on this site for a full calendar year.

We are an extremely small company and most of your extra questions are likely not applicable. Everything you need should be contained in the free vendor qualification package. Extra “asks” will be determined on a case-by-case basis. Email hello@toolval.com to inquire.

We will maintain our current tools and work to validate new versions quickly. If you would like us to support other tools/versions email hello@toolval.com and include the tool, version, configuration information, and how you use it (can be short). This information will save us from back-and-forth emailing. We maintain a list of tools (with configurations/versions) that we are working on, and we can scale FAST. Many times, we can complete requests in less than 2 weeks. If it’s a different version or extra library you need, we can do it quicker!