Back
Back
Back
Back
Back
Back
Back
Back
Back
Back
Back
Back
Back
Back
Back
With our support, the companies have always succeeded: all regulatory requirements are met, the FDA gives the green light, and product marketing can begin as quickly as possible.
We create your precise timetable, so you know exactly who has to do what and when. That means you can reliably plan your budgets and marketing and be sure you won't forget anything.
You communicate with one person who coordinates the entire project and ensures you don't create redundant QM or approval documents. That saves you time and money and increases your regulatory safety.
Your quick start to FDA approval of medical devices and IVDs
Our team of experts is ready to assist you! Get in touch.
We provide you with an experienced consultant as your personal contact who will accompany you throughout the entire project, coordinate the tasks to be completed, and involve the necessary experts at the right time to ensure that the project runs smoothly and in line with your goals.
Our experts will clarify the key questions with you right at the start:
Our FDA experts create product-specific documents for you, carry out gap analyses, and correct errors. We can take care of all documents on request, whether DHF, DMR, cover letters, or forms.
That means you have compliant approval documents in your hands that are specific to your device, the selected procedure, and the submission form, e.g., eSTAR. All you then have to do is submit them.
We ensure that
Learn more
We provide you with everything from a single source. This also applies if you do not yet have all the necessary evidence:
Targeted communication with the FDA almost always helps to clarify detailed questions and maximize the chances of obtaining authorization quickly and according to plan. We prepare these so-called “pre-submission meetings” together with you, help you answer any reviewer queries, and accompany you during the meeting. We also support you with requests for information in accordance with Article 513(g).
Even after the FDA successfully clears your device, you can count on us. We support you with the establishment registration and device listing and, if you wish, act as your US Agent. For this purpose, we use our Johner Institute North America subsidiary.
Learn more
Even if the FDA has already identified deviations or you have concerns, help is at hand. You can also rely on our support with remediation.
Contact us right away to make an appointment with one of our FDA experts and determine the first steps of your US market access.
Phone
+49 7531 94500 20
Contact Form
We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.
Here you will find an overview of all cookies used. You can give your consent to entire categories or have further information displayed and thus select only certain cookies.
These cookies are needed to let the basic page functionality work correctly.
Show Cookie Information
Hide Cookie Information
Google Tag Manager
Cookie from Google for controlling advanced script and event handling.
| Provider: | Google Ireland Limited, Gordon House, Barrow Street, Dublin 4, Ireland |
| Cookiename: | _ga,_gat,_gid |
| Runtime: | 2 Jahre |
| Privacy source url: | https://policies.google.com/privacy?hl=de |
Statistic cookies anonymize your data and use it. These information will help us to learn, how the users are using our website.
Show Cookie Information
Hide Cookie Information
Google Analytics
Tracking and analysis of traffic on our websites.
| Provider: | Google Inc. |
| Cookiename: | ga_*, gi_*, gat_gtag_* |
| Runtime: | 365 |
| Privacy source url: | https://policies.google.com/privacy |
| Host: | google.com |
Matomo
Tracking and analysis of traffic on our websites.
| Provider: | Matomo |
| Cookiename: | pk_ses*, pk_id* |
| Privacy source url: | https://matomo.org/privacy-policy/ |
Hotjar
Tracking visitor behaviour on our websites.
| Provider: | Hotjar |
| Cookiename: | _hjAbsoluteSessionInProgress, _hjSession_1170855, _hjSessionUser_1170855, _hjid, _hjIncludedInSessionSample |
| Runtime: | 1 |
| Privacy source url: | https://www.hotjar.com/legal/policies/privacy/ |
| Host: | hotjar.com |
Marketing cookies from thrid parties will be used to show personal advertisment. They use them to track users outside of their own web page.
Show Cookie Information
Hide Cookie Information
Hubspot
Tracking the identity of a visitor. It is passed on to HubSpot when a form is submitted and is used to deduplicate contacts.
It contains an opaque GUID that represents the current visitor.
In addition, cookies from LinkedIn are introduced for marketing purposes.
| Provider: | Hubspot |
| Cookiename: | hubspotutk, __hssrc, test_cookie, lidc, li_gc, lang, lang, bscookie, bcookie, _gcl_au, __hstc, __hssrc, __hssc ,__cf_bm, UserMatchHistory, AnalyticsSyncHistory |
| Runtime: | 730 |
| Privacy source url: | https://legal.hubspot.com/privacy-policy |
| Host: | .hubspot.com |
Conversion tracking from LinkedIn.
| Provider: | |
| Cookiename: | li_fat_id, li_giant, VID |
| Runtime: | 365 |
| Privacy source url: | https://www.linkedin.com/legal/privacy-policy?trk=content_footer-privacy-policy |
| Host: | .linkedin.com |
Meta
Conversion Tracking from Meta.
| Provider: | Meta |
| Cookiename: | _fbp, _fbc, _fbq |
| Runtime: | 365 |
| Privacy source url: | https://www.facebook.com/privacy/policies/cookies/ |
| Host: | facebook.com |
Content for Videoplatforms und Social Media Platforms will be disabled automaticly. To see content from external sources, you need to enable it in the cookie settings.
Show Cookie Information
Hide Cookie Information
Google Maps
Required to display maps. Google uses cookies here to identify and track users.
| Provider: | |
| Cookiename: | NID |
| Runtime: | 183 |
| Privacy source url: | https://policies.google.com/privacy?hl=de |
| Host: | google.com |
Hubspot Forms
Google Recaptcha for Hubspot forms.
| Provider: | Hubspot |
| Cookiename: | _GRECAPTCHA |
| Runtime: | 180 |
| Privacy source url: | https://policies.google.com/privacy?hl=de&fg=1 |
| Host: | js.hsforms.net |
