Do you want to ensure standards compliance to meet quality & regulatory requirements?
Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.)
Our new service helps you identify the required standards and editions for your intended markets.
Our service helps medical electrical device manufacturers (our specific focus of our database) keep up to date on new standards, updates to existing standards, and draft standards under development. This assures you can plan ahead of any major changes.
We reduce your burden on this time consuming task, so you can focus on what you are good at – developing products.
We do this at very reasonable rates. We are offering to early adopters an extra discount on the price and extra time (3 months) will be added to the first year subscription. 
See our demo page for the types of reports we generate for the service. Find out more about the service.
We decided to take a little extra time to capture the large amount of information involved.. We will be Live by Mid Oct 2015.
Sign-up now for a live release notification and you will receive a special limited time offer that no one else will receive after we go live!! If you would also like to receive our Eisner Safety Consultants Newsletter sign-up here. Also, early adopters get an extra discount on the price and will get an additional 3 months added to their first year subscription if you sign-up in time.
What does the Service Provide:
The service includes several databases:
- The Standards database is the primary focus. It includes standards, technical reports, technical specifications and guides. It includes new documents, updates to existing documents, as well as drafts under development (e.g. New Work Proposals, Committee Drafts, etc.)
- List of standards publishers and the associated country.
- List of Medical Device Regulators and their websites (if available).
- Guidance Documents related to the standards for key markets. [Coming Soon]
A periodic report** is provided as part of the service.
All paid subscribers will have the ability to:
- Run searches of subscribed databases
- Print out search results from displayed data
- Print out tables of results in tabular format
- Export data for generation of your own reports (based on terms of service)
- Multiple user log-in for your company (limited to 5 unique user log-ins)
Discount for Initial release: We are releasing the database in stages, the early adopters (Current stage – stage 1) will get a discount (20%) for the first annual subscription cycle and an additional 3 months added to their subscription if you sign-up in time.
Sign-
up now to receive a live release notification and you will receive a special limited time offer that no one else will receive after we go live!! If you would also like to receive our Eisner Safety Consultants Newsletter sign-up here.
Stage 2 will add Guidance Documents for the US, Canada, and EU. Also, list of standards publishers and the associated country will be expanded to cover 50+ countries. Stage 2 will be released by early 2016.
Stage 3 will expand the standards database to include US, EU, and Canadian versions of the IEC standards & IEC/ISO joint documents. It will also expand the regulators information and their websites beyond the key markets. Stage 3 will be released early Spring 2016.
Stage 4 will expand the standards database to include the supporting (non-electrical) medical standards used for your regulatory submissions e.g. ISO 10993 series, ISO 15223-1, etc. Stage 4 will be released early Fall 2016.
View details on the Subscription Levels
Please feel free to contact me with any questions you may have. I can be reached by e-mail or phone at and 503-244-6151 (Office) and 503-709-8328 (Cell).