Skip to main content

Consult

Full Name

Business Email

Contact Number

Message

How did you hear about us?

Other (Please specify)

I have read the privacy policy

Leave this field blank

Contact Us

Full Name

Business Email

Contact Number

Message

How did you hear about us?

Other (Please specify)

I have read the privacy policy

Leave this field blank

What are you looking for?

Search

Get in Touch

Name

Company

Business Email

Contact Number

Message

How did you hear about us?

Other (Please specify)

I have read the privacy policy

Leave this field blank

Let's Talk

Status message

Sorry… This form is closed to new submissions.

Leave this field blank

Partner With Us

First Name

Last Name

Company Name

Business Email

Contact Number

Best Time to Contact

Country

Message

I have read the privacy policy

Leave this field blank

Send Us a Request

Full Name

Business Email

Contact Number

Message

How did you hear about us?

Other (Please specify)

I have read the privacy policy

Leave this field blank

Talk to our experts

Full Name

Company

Business Email

Contact Number

Message

How did you hear about us?

Other (Please specify)

I have read the privacy policy

Leave this field blank

.

Get in Touch

Solutions
Medicinal Products
Medical Devices
Consumer
Freyr Digital
Medicinal Products Regulatory Services
Regulatory Affairs
Regulatory Operations
Regulatory Medical Writing
Regulatory Pharmacovigilance
Medical and Scientific Communication
Compliance, Audit, and Validation
Global Regulatory Intelligence
MPR - Regulatory Affairs Menu Block
Drug Development Regulatory Services
Regulatory Strategy and Insights
Dossier Authoring
Post Approval/Lifecycle Management
Country-specific Regulatory Services
Global Health Authorities-Specific Services
EU CTR Submissions

MPR - Regulatory Operations Menu
Regulatory Publishing and Submissions
Regulatory Labeling Services
Regulatory Artwork Services

MPR - Medical Writing Menu Block
Clinical Services
Non-Clinical Services
Regulatory Toxicology Services
Clinical and Non-Clinical Consulting and Strategic Services
Automation in Medical Writing

MPR - Pharmacovigilance Menu Block
Literature Monitoring
ICSR Management
Aggregate Reporting
Pharmacovigilance Risk Management
Signal Management
Audit Support and Training Compliance
Quality Assurance and Analysis
Local Safety Representation
Safety Regulatory Intelligence
Database Services & Technology Solutions

MPR - Medical & Scientific Communication Menu Block
Manuscripts and Publications
Promotional and Non-promotional Content Curation
Creative Scientific Design Studio
Promotional Materials Review - MLR
FDA Ad Promo Submissions - OPDP 2253
Content Management

MPR - Compliance and Audit Services Menu Block
CAS Consulting
SOP Development
GxP Audit
CSV and CSA
QMS Remediation & Establishment
End-to-end Compliance Services

MPR - GRI Menu Blocks
Global Regulatory Intelligence

Medical Devices Regulatory Services
Market Access
Regulatory Affairs
Clinical & Performance Evaluation
Quality, Compliance, & Audit
Digital Health
Human Factors Engineering
Global Regulatory Intelligence
MDV - Market Access menu block
Device Registration Americas
Device Registration Europe
Device Registration China
Device Registration Japan
Device Registration South Korea
Device Registration Australia
Device Registration: Rest of the World
In-Country Representation

MDV - Regulatory affairs services menu block
Translation Support
Device Documentation
Labeling Services
Artwork Services
Technical Writing Services
RA Staff Augementation Services
Regulatory Consulting

MDV - Medical Writing services menu block
Clinical Evaluation
Performance Evaluation
Post Market Surveillance
Lifecycle Management
Literature Search Protocol and Review

MDV - Quality Management System services menu block
ISO 13485 Certification
MDSAP
FDA 21 CFR Part 820 Quality System Regulation (QSR)
ISO 14971 Risk Management Consulting

MDV - Digital Health/SaMD services menu block
SaMD Registration in the US
SaMD Registration in the EU
Australia TGA Software as Medical Devices (SaMD) Registration
SaMD Registration in South Korea

MDV - Human Factors Engineering for Medical Devices menu Block
Human Factors Engineering for Medical Devices

MDV - GRI Menu Blocks
Global Regulatory Intelligence

Consumers
Cosmetics
Food Supplements
Chemicals
Spotlight
COS - Cosmetics services1 Menu
Formulation and Ingredient Review
Labeling Review
Claims Review
Safety Assessment And Toxicology
Cosmetic Product Information File (PIF)
Go-to-market and Legal Representative (LR)

COS - Cosmetics services2 Menu
Cosmetic Testing
Modernization of the Cosmetics Regulation Act of 2022 (MoCRA)
Cosmetic Regulatory Intelligence
EUDR Compliance Services for Cosmetics Industry | Freyr Solutions
Global Regulatory Intelligence

FDS - Service1 Menu block
Food Product Service
Food Product Claims Substantiation
Food Labeling Requirements and Claims Review
Food Product Dossier Compilation
Food Legal Representation
Ecolabeling Regulatory Support
GMPs for Dietary Supplements
Food Regulatory Pathway Reports

FDS - Service2 Menu block
Food Product Compliance
Food Ingredient Assessment and Food Formulation Review
Food Supplement Classification
Food Supplement Registration
Alcoholic Beverage Regulatory Compliance
EUDR Compliance Services for Food Industry | Freyr Solutions

FDS - Service3 Menu block
Novel Food Registration
NDIN/GRAS (US/US FDA)
US FDA Food Facility Registration

Global Regulatory Intelligence
CSRA - Chemicals service1 Menu
Chemical Data Scouting
Chemical Scientific Assessment Reports and Position Paper Report
Supply Chain Regulatory Compliance
Chemical Packaging Regulations
Biocidal Product Disinfectants - Biocidal Product Regulations
Regulation of Tobacco Products
Ecolabeling Regulatory Support
Chemical Safety Data Sheet

CSRA - Chemicals service2 Menu
Pet Care Products Registration
General Product Safety Regulation (GPSR)
Global REACH Regulatory Compliance
Chemical Toxicological Risk Assessment
EUDR Compliance Services for Chemical & general consumer product | Freyr Solutions
Global Regulatory Intelligence

EUDR Compliance I Food, Cosmetics & Chemicals
Freyr Digital
Stay Ahead of the Curve With Our Innovative Regulatory Software Solutions
At the heart of Freyr Digital’s suite of Regulatory software prowess lies the knowledge we have gathered over decade. In a world overflowing with data, we navigate with wisdom, carve out new paths with creativity, and drive forward with the most advanced tech solutions. Know More
Consumer
Medicinal products
Regulatory Affairs Services
Drug Development Regulatory Services
Pre-submission Meetings/HA Interactions
Clinical Trial Applications
Regulatory Strategy and Insights
Regulatory Strategy Consulting
Regulatory Submission Roadmaps/Regulatory Intelligence
Regulatory Staffing Services
Global Regulatory Affairs Services
Gap Analysis
Artificial Intelligence (AI)-powered Regulatory Services
Dossier Authoring
CTD Templates
End-to-end DMF Registration
Post Approval/Lifecycle Management
Post-Approval Change Submissions
Nitrosamine impurity Risk Assessment
Country-specific Regulatory Services
Global Health Authorities-Specific Services
EU CTR Submissions
Regulatory Operations
Regulatory Publishing and Submissions
AI-powered Regulatory Services
eCTD Publishing and Submission Services
NeeS Submissions
Paper Submissions
CSR - Report-Level Publishing
Legacy Conversions
AD promo submission services
Archiving Services for Regulatory Publishing and Submission
Data Migration Services
Document Formatting
Submission QC Automation
Auto Document Level Publishing
Regulatory Labeling Services
Strategic Labeling Consulting
Process Consulting
Technology Consulting
Content Harmonization & Standardization
Go-to-market Labeling Strategies
Labeling Translation
Translation Creation & Updation
Translation Quality Check
Translation Coordination
Regional Labeling
USPI Preparation
EUSMPC Preparation
ROW Labeling
Linguistic Review
SPL/SPM (Creation & Updation)
Competitor Label Analysis
Label Comparison
Monitoring Reference Label Changes
Readability Test
Global Labeling
CCDS/CSI Creation & Updation
Monitoring CCDS Change implementation and Deviation Management
Local Justification Document Preparation
Clinical Labeling
Target Product Profiling (TPP)
Developmental CCDS Creation & Updation
Labeling Automation
Labeling Content Management
Labeling Templatization
Large-volume Change Automation
End-to-end Tracking
e-labeling
AI-powered Regulatory Labeling Services
Pharma Labeling Compliance
Regulatory Artwork Services
Content to Carton
Artwork Studio
Packaging Design Template Creation
Changes to Existing Artwork
Private Label Artwork Services
Artwork Review / Quality Check
Print proof QC
Artwork Lifecycle Coordination
End-to-End Artwork Workflow Coordination
Packaging Artwork Process Consulting
Artwork Management System
Artwork Workflow Management
Artwork Automation
Artwork Regulatory Intelligence
ELeaflet/eLabel
Pharmacovigilance
Literature Monitoring
ICSR Management
Aggregate Reporting
Pharmacovigilance Risk Management
Signal Management
Audit Support and Training Compliance
Quality Assurance and Analysis
Local Safety Representation
Safety Regulatory Intelligence
Database Services & Technology Solutions
Medical Writing
Clinical Services
Regulatory Writing Services
Clinical Trial and Consulting Services
Clinical Trial Audit and Monitoring Services
Quality Check and Medical Review of Regulatory Documents
Risk-Benefit Analysis
Data Transparency Initiatives
Non-Clinical Services
Regulatory Toxicology Services
ADE/PDE Determination/Report Services
F-Value Reports for Child Resistant Packaging (CRP)
Toxicological Risk Assessment (TRA) of Impurities, Extractables and Leachables
Environmental Risk Assessment (ERA) of Medicinal Products
Clinical and Non-Clinical Consulting and Strategic Services
Clinical Writing Consulting and Strategic Services
Technical Writing Support for GxP Compliance
Business Process Optimization
Non-clinical Consulting & Strategic Services
Automation in Medical Writing
Narrative writing tool
Literature review tool
Formatting tool
Quality review tool
End-to-End Medical Writing
Compliance and Audit Services
CAS Consulting
SOP Development
GxP Audit
Remote and Virtual Audits
CSV and CSA
QMS Remediation & Establishment
End-to-end Compliance Services
Medical and Scientific Communication
Manuscripts and Publications
Promotional and Non-promotional Content Curation
Content Development
Peer Review and QC
Creative Scientific Design Studio
Promotional Materials Review - MLR
FDA Ad Promo Submissions - OPDP 2253
Content Management
Global Regulatory Intelligence
Global Regulatory Intelligence
Medical Devices
Market Access
Device Registration Americas
USA
e-Star
513(g)
510(k)
Q-submission
Pre-market Approval
RFD & Pre-RFD
UDI and GUDID Solutions for the FDA Compliance
Canada
Canada ISED Representative Service
Medical Device Establishment Licence (MDEL) Solutions for Canada
Medical Device Importer Solutions for Compliance in Canada
Medical Device Licence (MDL) Solutions for Canada
Device Registration Europe
EAEU
EU MDR
EU IVDR
Europe
UK
Switzerland
Device Registration China
Device Registration Japan
Device Registration South Korea
Device Registration Australia
Device Registration: Rest of the World
In-Country Representation
Australian TGA Sponsor
Korean Registration Holder (KRH)
Mexican Registration Holder (MRH)
US Agent
European Authorized Representative (EAR)
Swiss Authorised Representative (CH-Rep)
UK Responsible Person (UKRP)
Designated Market Authorization Holder (DMAH)
China Agent Services
Brazil Registration Holder (BRH)
Indian Authorization Agent for Medical Device Registration in India
In-country representation Rest of the world
Regulatory Affairs
Translation Support
Device Documentation
Device History File
Device Technical File Publishing
Labeling Services
Artwork Services
Technical Writing Services
RA Staff Augementation Services
Regulatory Consulting
Life cycle management
Medical Device Consulting
IVD Consulting
SaMD Consulting
Combination product Consulting
Regulatory Intelligence
Device classification & Categorization
Clinical and Performance Evaluation
Clinical Evaluation
Clinical Evaluation Plan (CEP)
Clinical evaluation report (CER)
Performance Evaluation
Scientific Validity Report (SVR)
Clinical Performance Report (CPR)
Analytical Performance Report (APR)
Performance Evaluation for In Vitro Diagnostic Medical Devices
Performance EvaluationReport (PER) IVDR
Post Market Surveillance
Post-Market Surveillance (PMS)
Periodic Safety Update Report (PSUR)
Lifecycle Management
Literature Search Protocol and Review
Quality, Compliance, and Audit
ISO 13485 Certification
MDSAP
FDA 21 CFR Part 820 Quality System Regulation (QSR)
ISO 14971 Risk Management Consulting
Digital Health
SaMD Registration in the US
SaMD Registration in the EU
Australia TGA Software as Medical Devices (SaMD) Registration
SaMD Registration in South Korea
Human Factors Engineering for Medical Devices
Human Factors Engineering for Medical Devices
Global Regulatory Intelligence
Global Regulatory Intelligence
Cosmetics
Cosmetics Services
Formulation and Ingredient Review
Labeling Review
Claims Review
Safety Assessment And Toxicology
Cosmetic Product Information File (PIF)
Go-to-market and Legal Representative (LR)
Cosmetics Service
Cosmetic Testing
Modernization of the Cosmetics Regulation Act of 2022 (MoCRA)
Cosmetic Regulatory Intelligence
EUDR Compliance Services for Cosmetics Industry | Freyr Solutions
Global Regulatory Intelligence
Food Supplements
Food Product Service
Food Product Service
Food Product Claims Substantiation
Food Labeling Requirements and Claims Review
Food Product Dossier Compilation
Food Legal Representation
Ecolabeling Regulatory Support
GMPs for Dietary Supplements
Food Regulatory Pathway Reports
Food Product Compliance
Food Product Compliance
Food Ingredient Assessment and Food Formulation Review
Food Supplement Classification
Food Supplement Registration
Alcoholic Beverage Regulatory Compliance
EUDR Compliance Services for Food Industry | Freyr Solutions
Novel Food Registration
Novel Food Registration
NDIN/GRAS (US/US FDA)
US FDA Food Facility Registration
Chemicals
CSRA Services
Chemical Data Scouting
Chemical Scientific Assessment Reports and Position Paper Report
Supply Chain Regulatory Compliance
Chemical Packaging Regulations
Biocidal Product Disinfectants - Biocidal Product Regulations
Regulation of Tobacco Products
Ecolabeling Regulatory Support
Chemical Safety Data Sheet
CSRA Services
Pet Care Products Registration
General Product Safety Regulation (GPSR)
Global REACH Regulatory Compliance
Chemical Toxicological Risk Assessment
EUDR Compliance Services for Chemical & general consumer product | Freyr Solutions
Global Regulatory Intelligence
Global
Americas
Europe
Asia-Pacific
Africa & Middle East
Global Americas Menu Block
Argentina
Bolivia
Brazil
Canada
Chile
Colombia
Costa Rica
Dominican Republic
Guatemala
Mexico
Panama
Paraguay
Peru
Puerto Rico
United States
Venezuela

Global Europe Menu Block
Albania
Austria
Belarus
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
European Union
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Kazakhstan
Kosovo
Latvia
Lithuania
Luxembourg
Macedonia
Malta
Netherlands
Norway
Poland
Portugal
Romania
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom
Uzbekistan

Global Asia - Pacific Menu Block
Australia
Bangladesh
Cambodia
China
Hong Kong
India
Indonesia
Japan
Malaysia
New Zealand
Pakistan
Philippines
Russia
Singapore
South Korea
Sri Lanka
Taiwan
Thailand
Vietnam

Global Africa & Middle East Menu Block
Algeria
Bahrain
Egypt
Ethiopia
Ghana
Iraq
Israel
Jordan
Kenya
Kuwait
Lebanon
Morocco
Nigeria
Qatar
Saudi Arabia
South Africa
Tunisia
Turkey
UAE
Uganda
Yemen
Zimbabwe
Americas
Argentina
Bolivia
Brazil
Canada
Chile
Colombia
Costa Rica
Dominican Republic
Guatemala
Mexico
Panama
Paraguay
Peru
Puerto Rico
United States
Venezuela
Europe
Albania
Austria
Belarus
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
European Union
Greece
Hungary
Ireland
Italy
Kazakhstan
Kosovo
Latvia
Lithuania
Luxembourg
Macedonia
Malta
Netherlands
Norway
Poland
Portugal
Romania
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom
Uzbekistan
Asia-Pacific
Australia
Bangladesh
Cambodia
China
Hong Kong
India
Indonesia
Japan
Malaysia
New Zealand
Pakistan
Philippines
Russia
Singapore
South Korea
Sri Lanka
Taiwan
Thailand
Vietnam
Africa & Middle East
Algeria
Bahrain
Egypt
Ethiopia
Ghana
Iraq
Israel
Jordan
Kenya
Lebanon
Morocco
Kuwait
Nigeria
Qatar
Saudi Arabia
South Africa
Tunisia
Turkey
UAE
Uganda
Yemen
Zimbabwe
Customers
Success Stories
Case Studies
Testimonials
Insights
Blogs
Brochures
Infographics
Webinars
Freyr Podcasts
What is ...?
White Papers
e-Books
Global Health Authority Mandates
Regulatory Roundup
Templates and Checklists
Industry News
Videos
Company
About Us
Awards & Recognitions
Press Releases
Freyr in Media
Industry Events
Compliance Wall
Corporate Social Responsibility
Functional Delivery Models
Careers
Partner with Us
Contact Us

Get in Touch
English
- Japan (Japanese | English)
- South Korea (Korean | English)
- China (Chinese | English)
- Mexico (Español | English)
- Brazil (Portuguese | English)
- Australia (English)
- Sri Lanka (English)
- India (English)
- Malaysia (English)
- Nigeria (English)
- Saudi Arabia (English)
- Thailand (English)
- sales@freyrsolutions.com
- hr@freyrsolutions.com

Breadcrumb

Home
Freyr Blogs
Software As Medical Devices (SaMDs)
Blog Tags
Software as Medical Devices (SaMDs)

Software as Medical Devices (SaMDs)

March 10, 2023
RDC 751 - ANVISA’s New Resolution for Medical Devices

How can we help you?

Please let us know your requirements, and we will contact you.

I have read the privacy policy

Leave this field blank

+1 908 483 7958

+44 203 701 2379

+91 40 4848 0999

+27 105 002 556

sales@freyrsolutions.com

Connect with Us

Terms of Use | Privacy Policy | Cookie Policy | Customize Cookies

© Copyright 2024 Freyr. All Rights Reserved.