Skip to content
  • ABOUT
  • PRODUCTS
    • SERVICES
      • 3D Modelling Service
      • Regulatory consulting
      • Custom Development
    • SOFTWARE
      • Segment CMR
      • Segment 3DPrint
      • Segment CT Research
      • Segment Pre-clinical
      • Segment Research
      • Strain analysis module
      • AI AutoMate
    • Seamless clinic – research solution
    • QMS Point-of-Care
  • DOWNLOAD
  • RESOURCES
    • News
    • FAQ
    • Software Support
    • User Manuals
    • Tutorial videos
    • Validation / Refer to Segment
    • Segment Publications
  • CONTACT
Menu
  • ABOUT
  • PRODUCTS
    • SERVICES
      • 3D Modelling Service
      • Regulatory consulting
      • Custom Development
    • SOFTWARE
      • Segment CMR
      • Segment 3DPrint
      • Segment CT Research
      • Segment Pre-clinical
      • Segment Research
      • Strain analysis module
      • AI AutoMate
    • Seamless clinic – research solution
    • QMS Point-of-Care
  • DOWNLOAD
  • RESOURCES
    • News
    • FAQ
    • Software Support
    • User Manuals
    • Tutorial videos
    • Validation / Refer to Segment
    • Segment Publications
  • CONTACT
Login/Logout

REGULATORY CONSULTING

We provide service for high quality regulatory consulting according to your needs

We can provide a complete package for getting your medical software product ready for CE-marking and/or FDA 510(k) application. We are specialised in the regulatory framework for medical image analysis software and have more than 10 years of experience in the field. We offer very broad and flexible regulatory consulting, everything from smaller consulting projects, to basic education, to a complete regulatory package to take your product from idea to regulatory compliance.

CONTACT US
CUSTOMER REVIEWS

Benefits

  • Reduce cost by get a complete package for your company to implement quality system, train employees, provide you with templates and checklists to easily follow all regulatory requirements.
  • Save time by our efficient and optimized implementation plan
  • Added value for you company to have regulatory approvals
  • We support you in every step to ensure you get an efficient quality system adapted to your company structure

The regulatory training we offer aims to provide sufficient knowledge to enable you to implement the quality system in your business and apply the CE marking and/or FDA regulations for your product with good confidence.

With the templates, checklists and training included, we expect you to save many months of work and minimize the cost for the reviewing process by regulatory authorities. Following our well-prepared implementation process is cost-effective and time-efficient compared to find out everything on your own or have massive feedback from Notified Body / FDA in the review process. An implemented quality system that meets regulatory requirements is a great added value for the company, for example, in valuation and financing.

Follow Us

  • Opens in a new tab
  • Opens in a new tab

Contact Information

Medviso AB
Griffelvägen 3
SE-224 67, Lund, Sweden
info@medviso.com

Interested in a trial?
Send your request to:
sales@medviso.com

Customer Support

FAQ

Send your support request to:
support@medviso.com

How to make support request

 

COMPANY

Regulatory Approvals

Privacy Policy

Partners

Customer Testimonials

© Medviso.com. All rights reserved.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
Cookie SettingsAccept All
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT