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MedTech

Regulations for Medical Devices 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.  

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MedTech

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, ​
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Device intellectual property assessment and competitor analysis 

Reimbursement requirements 

Regional regulatory and documentation requirements as per device classification

Labeling requirements 

Registration timelines and importation process to
assess time to market 

GMP requirements

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Medical Device Regulatory and Quality Affairs

Based on medical device registration strategy, Artixio is helping its clients with,

QMS review and regulatory assessment (ISO 13485,

21 CFR Part 820)

Product Registration 

Technical Documentation Review  
 

Dossier Preparation 

Response to Health Authority Queries
 

Device classification 

 

Technical and Medical Writing

We are supporting our clients with medical and technical writing for medical devices. The services include, ​​
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Authoring Biological Evaluation Reports as per
ISO 10993-1

Post Marketing Surveillance Reports 

Authoring Performance Evaluation Reports (PER)
 

Clinical Evaluation Reports
 

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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 

Assistance with Distribution and Import of Devices 

Address safety concerns

Renewals and Annual Reports Submission 
 

Health Authority Interactions ​
 

Our Medical Devices & Diagnostics Categories Experience

MedTech Categories Experience

Ophthalmic

  • Contact lenses

  • Lens care products

  • Diagnostics

  • Implants

  • Intraocular lenses

  • Lasers

  • Phacoemulsification systems

  • Solutions (including artificial tears)

  • Surgical instruments

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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

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)​​

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

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)

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

Combination Device

  • Electroporation device

  • Derma abrasion device with cosmetics

  • Insulin pen device

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Orthopaedic

  • Suture anchors

  • Surgical spoons

  • Angled jaws and instrument trays

  • Orthopaedic

  • Implants

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Artixio's Services for EU MDR & IVDR Compliance

Learn more about Artixio's services for Medical Devices and IVDs

Insights Related to Medical Devices

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Get in touch

Our experts will be delighted to assist you with your global business needs.

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