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End to End Compliance Services for MedTech Industry
Regulations for Medical Devices are evolving worldwide, increasing the complexities in managing global
regulatory compliance. Artixio is supporting its clients with end to end commercial opportunity assessment
and commercialization of medical devices in global markets using integrated regulatory services.
Global, Regulatory Intelligence Driven, Tech Assisted, Integrated Services Excellence for Medical Devices and Diagnostics
Regulations for Medical Devices and diagnostics are evolving worldwide, increasing the complexities in managing global regulatory compliance. Artixio is supporting it’s clients with end to end commercial opportunity assessment and commercialization of medical devices in global markets using integrated regulatory services.
Services:
Regulatory Affairs
Technical and Medical Writing
Regulatory AI Consulting
Product Registration
Regulatory Intelligence & Strategy
EU MDR Gap Assessment
Medical Devicec Regulatory Intelligence & Strategy
Planning for registration of medical device in a country or multiple countries require right
regulatory strategy based on country specific documentation, quality and clinical data
requirements. Artixio’s regional experts and experienced medical device leaders can provide
right guidance and strategy for global registration using,
Medical Device Regulatory and Quality Affairs
Based on medical device registration strategy, Artixio is helping its clients with,
Device intellectual property
assessment and competitor analysis
Regional regulatory and
documentation requirements
as per device classification
Registration timelines
and importation process
to assess time to market
Reimbursement
requirements
Labeling requirements
GMP requirements
Technical and Medical Writing
We are supporting our clients with medical
and technical writing for medical devices.
The services include,
Authoring Biological
Evaluation Reports
as per ISO 10993-1
Authoring Performance
Evaluation
Reports(PER)
Post Marketing
Surveillance Reports
Surveillance Reports
Clinical Evaluation
Reports
Reports
Authorized Agent / Legal Representation
With our global presence, necessary
sanitary licenses and regional affiliates,
Artixio is representing its clients to Health
Authorities responsible for submission and
response to health authority queries. As an
authorized agent, we can support with,
Legal representation
before and after
approval of products
Health Authority
Interactions
Renewals and Annual
Reports Submission
Assistance with
Distribution and Import
of Devices
Address safety
concerns
Artixio's Services for EU MDR & IVDR Compliance
Clinical Evaluation of Medical Devices
Performance Evaluation Reports (PER)
EU 2017/745 Medical Device Regulations
EU MDR Gap Assessment
Summary of Safety & Clinical Performance
Device classification
Our Medical Devices and Diagnostics Categories Experience
Diagnostics
- Medical imaging
- Optical Tissue Imaging System (OTIS)
- Intraoral dental 3D scanner
- Medical endoscopes, ultrasound
- Refrigerated centrifuges for blood
- Implantable defibrillators
- Non-refrigerated centrifuges for blood
- Blood collection vacuum tubes
- Blood sampling devices
- Thermometers
Active Implantable Medical Devices
- Implantable cardiac pacemakers and accessories
- Implantable neurostimulator systems
- Brachytherapy systems
- Cochlear implants and accessories
- Implantable glucose monitors
- Implantable defibrillators
- Leads, electrodes, adaptors for implantable pulse generators
- Ventricular Assist Devices (VADs)
- Implantable infusion pumps
- Micro Electro-Mechanical Systems (MEMS)
Ophthalmic
- Contact lenses
- Lens care products
- Diagnostics
- Implants
- Intraocular lenses
- Lasers
- Phacoemulsification systems
- Solutions (including artificial tears)
- Surgical instruments
Vascular
- Cardiac electrophysiology and ablation catheters
- Catheters for intravascular and intracardiac imaging
- Devices for the treatment of Abdominal Aortic Aneurysms (AAA), neurovascular diseases; structural heart defects or disease
- Drug-eluting stents, bare metal stents, and bioresorbable stents
- Embolic filters and IVC filters
- Guide catheters, balloon catheters, CVCs, introducers, filters, guidewires, PICCs, and related tools
- Renal artery denervation devices
Mobile Devices
- Integrated device
- Video capsule endoscopy
- Devices for artificial limbs
- Implanted wireless sensors and devices
- Wearable wireless sensors and devices
- Mobile apps
- Ingestible sensors
SaMD
- Infusion pump rate setting assistance software
- Picture Archiving and Communication Software (PACS)
- Image processing software
- Standalone application software for collecting patient data
- Standalone software for implantable devices
- Apps for phones (e.g., ECG, radiation therapy planning software)
Combination Device
- Electroporation device
- Derma abrasion device with cosmetics
- Insulin pen device
Orthopaedic
- Suture anchors
- Surgical spoons
- Angled jaws and instrument trays
- Orthopaedic
- Implants
Why Artixio?
Industry Recognized (CPHI Pharma Awards 2024) Tech-Enabled, Regulatory Intelligence driven Services
Ensuring compliance for 200+ Devices and Diagnostics Products Licenses
120+ Countries supported
Inhouse Regulatory Experts with 15-30+ Years of Experience
End to End Support from Product Conceptualization to Launch and Post Market Support
Wide Product Experience: Devices, Diagnostics, Combination Drugs, Software as Medical Devices (SaMD), Consumer Devices
Diverse Experience across Complex Therapeutic areas and Application Areas
ISO 9001:2015, Quality Driven Services Platform
Flexible Business Models – Project Based; Long Term FTE based
Customer Focused, Nimble Team
FAQs
1. What are key components of global go to market strategy for medtech industry?
Medical Devices and diagnostic companies intending to expand in regional or international countries need to consider the following parameters for a comprehensive, long-term strategy. The parameters are: market opportunity, key competition, regional pricing, laws and regulations on product pricing, government incentives, key regulations, documentation requirements, process, timelines and cost for product registration, key regulatory compliance requirements post approval/market, safety and pharmacovigilance requirements, quality requirements and audit planning for health authorities inspection and vendor qualification and other parameters.
2. How do you provide global services to medical devices and diagnostics companies?
Artixio’s team members are based in countries across North America, Latin America, Europe, Middle East, Asia Pacific and CIS countries through its offices and extended affiliate network. Our team members have 10-30+ years of experience in successfully launching pharmaceutical products in respective countries and regions. Coupled with Artixio’s central project management team, our clients seamlessly plan and manage their global plans.
3. How do you stay up to date with regulations in different countries?
Artixio’s regulatory intelligence platform, nominated for CPHI Pharma Awards 2024, tracks changes in regulations in real time and our centralized regulatory intelligence team analyses the impact of those changes in different areas. Artixio’s regional teams are part of regulatory and industry associations locally, that provides first hand access to intelligence current and potential changes.
4. How do you manage projects with multiple products, product categories areas and countries?
Our inhouse experts based in different countries have proven experience across wide and complex medical device categories. They have successfully managed multiple product development and registration for leading global devices and diagnostic companies. Artixio’s centralized project management team makes it easy for our clients maintain project oversight across markets levering project management best practices and quality management systems.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
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