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Medical Device Compliance Consulting Services
Helping medical device companies meet regulatory and quality requirements across global markets with expert-led consulting services, so nothing slows down your launch.
Medical Devices Global Regulatory Partner
Artixio helps medtech and diagnostics companies get approved and stay compliant in 120+ markets.
International medical device approval isn’t what it was few years ago. What cleared last year won’t necessarily clear it this year and most delays trace back to documentation gaps. Artixio closes that gap.
We identify the markets with the most realistic timelines for your device and flag documentation and labeling issues before they delay your submissions. And most importantly, we keep regulatory strategy moving instead of getting stuck in reviews.
Our Medical Device Regulatory Services
Device Classification
Technical and Medical Writing
Regulatory Affairs
PMS & Lifecycle Maintenance
Authorized Agent / Legal Representation
Product Registration
Regulatory Publishing & Submissions
Clinical, Performance Evaluation
Regulatory Intelligence & Strategy
EU MDR Gap Assessment
Global Medical Device Consulting Services
1. Device Classification
We determine your device’s regulatory classification across major global regulatory frameworks, including FDA, EU MDR and other country specific classification systems. This ensures every next step, from registration and documentation to approvals, is built on the right foundation from day one.
- FDA Classification (I/II/III)
- EU MDR classification (I/IIa/IIb/III)
- EU IVDR Classification (A/B/C/D)
- Risk-Based Pathway Assessment
- Predicate Device Comparison
2. Medical Device Regulatory Affairs
We manage device intellectual property assessment, documentation and compliance strategy tailored to each market’s requirements.
- IP & Competitor Analysis
- Documentation Requirements
- Timelines & Import Process
- Reimbursement
- Labeling
- GMP Requirements
3. Technical & Medical Writing
We author the technical and medical documents health authorities require, throughout your device’s lifecycle.
- Biological Evaluation Reports (ISO 10993-1)
- Performance Evaluation Reports
- Post-Marketing Surveillance Reports
- Clinical Evaluation Reports
4. Regulatory AI Consulting
We help medtech companies apply AI and automation to regulatory work by tracking global rule changes, speeding up document drafting and reducing manual research so your team can focus more on strategy.
- Predicate Device Analysis (QuriousRI)
- Digital Health & MedTech Innovation Consulting
- Custom AI Tool Development
- Regulatory Data Analytics
5. Product Registration
We manage the end-to-end registration process for your device, covering dossier preparation, submission and regulatory approval across 120+ markets.
- Market Access Strategy
- Dossier Preparation & Submission
- QuriousRI-Assisted Registration
- Milestone-Based Project Management
6. Regulatory Intelligence & Strategy
We map the right regulatory path for your device, country by country, using our regulatory intelligence platform, QuriousRI and hands-on regional expertise.
- QuriousRI Regulatory Monitoring
- QuriousRI-GP Pathway & Gap Analysis
- Regional Experts (120+ Countries)
- Multi-Country Regulatory Comparison
7. Post-Market Surveillance & Lifecycle Maintenance
Approval isn’t the finish line. We help you manage what comes next, including safety reporting, complaint handling, manufacturing and labeling updates and keeping your registrations up to date in every market.
- MDR Post-Market Surveillance
- Vigilance Reporting
- Technical Documentation Updates
- Manufacturing & Label Change Management
8. Regulatory Publishing & Submissions
Once your technical documentation is ready, we handle the formatting and filing of 510(k), PMA, EU MDR technical files, and regulatory dossiers for other countries in the exact structure required by each health authority.
- Clinical Evaluation
- Performance Evaluation Reports for Medical Devices
- EU 2017/745 Regulations
- Classification for Medical Devices
- EU 2017/746 (IVDR)
- IVDR risk classification (A/B/C/D)
- Performance Evaluation Reports for IVDs
9. Authorized Agent / Legal Representation
With our global presence and regional affiliates, we represent you before Health Authorities for submissions, responses to health authority queries and regulatory communications across 120+ markets.
- Legal Representation Before/After Approval
- Health Authority Interactions
- Renewals & Annual Reports
- Distribution & Import Assistance
Medical Devices Regulatory Intelligence and Strategy
Medical Device Regulatory and Quality Affairs
Based on medical device registration strategy, Artixio is helping its clients with compliance consulting for medical devices.
Device intellectual property
assessment and competitor analysis
Technical and Medical Writing
We are supporting our clients with medical
and technical writing for medical devices.
The services include,
Surveillance Reports
Reports
Authorized Agent / Legal Representation
Artixio's Services for EU MDR and IVDR Compliance
Clinical Evaluation of Medical Devices
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
AI Powered Medical Device Platforms by Artixio
Our proprietary AI platform combine regulatory intelligence with automation to help teams make faster decision and maintain compliance across global markets.
QuriouousRI
Regulatoty Intelligence
ArtworkIQ
Label and Artwork management
SafetyIQ
Safety and Pharmacovigilance
Why Artixio for Medical Devices Consulting Services?
Why Artixio for Medical Devices Consulting Services?
120+ Countries
15-20 Yrs Experience
ISO 9001:2005 Certified
Global Search
- Regulatory coverage across 120+ countries, including FDA, CE, PMDA, HSA, CDSCO, MFDS and more
- Trusted by startups and global MedTech brands
Expertise
- Senior regulatory experts with 15-30+ years of experience
- Expertise across low-risk to high-risk medical devices
- Specialized in SaMD, diagnostics, combination products and AI/ML-enabled devices
How We Work
- Strategy-first planning from development to launch
- End-to-end lifecycle support
- Flexible consulting or dedicated FTE support
- Powered by QuriousRI, ArtworkIQ and Safety IQ
Trust & Quality
- CSDT, STED, 510(k), PMA, and EU MDR dossier preparation
- ISO 9001:2015 certified systems and compliance processes
FAQs
What happens after I request for the medical device regulatory consultation?
Once you request us a device related regulatory consulting service, we’ll talk through your device, your target markets and where you currently stand in development. Artixio’s regulatory experts will assess your requirements and identify the approval pathway that fits best. They’ll also point out any gaps in your documentation along the way. By the end you’ll receive a clear action plan in hand, complete with timelines, regulatory requirements and the support you needed to move your product toward approval.
How long does a typical EU MDR or FDA 510(k) engagement take?
The timeline depends on your device type, classification, the submission pathway you are on and how complete your technical documentation already is. Preparing a submission can take anywhere from a few weeks to several months, while regulatory review timelines vary by authority. We’ll get a clearer picture of where you stand during your consultation and from there, we can give you the realistic timeline based on your target markets and what the regulations require.
What are key components of global go to market strategy for medtech industry?
How do you provide global services to medical devices and diagnostics companies?
How do you stay up to date with regulations in different countries?
How do you manage projects with multiple products, product categories areas and countries?
Regulatory Expertise Across
Multiple Countries
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