ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
top of page
Extensive Technology Experience
-
Contact lenses
-
Lens care products Diagnostics
-
Implants
-
Intraocular lenses
-
Lasers
-
Phacoemulsification systems
-
Solutions (including artificial tears)
-
Surgical instruments
Ophthalmology
-
Suture anchors
-
Surgical spoons
-
Angled jaws and instrument trays
-
Orthopaedic Implants
Orthopedic
-
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
Vascular
-
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)
SaMD
-
Electroporation device
-
Derma abrasion device with cosmetics
-
Insulin pen device
Combination Device
-
Implantable neurostimulator systems
-
Implantable cardiac pacemakers and accessories
-
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)
Active Implantable
Medical Devices
-
Integrated device
-
Video capsule endoscopy
-
Devices for artificial limbs
-
Implanted wireless sensors and devices Wearable wireless sensors and devices
-
Mobile apps
-
Ingestible sensors
Mobile devices
-
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
Diagnostics
Lifecycle Management of
50+ Drugs and Devices
Partnered with 5 Leading Pharma and Medtech Companies Worldwide
80K+ Hours of Services
Delivered Annually
Our global team members bring decades of experience across the Medical Devices, Software as Medical Devices (SaMD) and In Vitro Diagnostics (IVD) product life cycles. A unique combination of product development, compliance, quality, clinical, commercial and digital teams position us as your partner of choice for all your MedTech business needs.
Get a Tailored Strategy for Your Product with MedTech Innovators
Medical Device Prototyping
Hybrid Application Development
Data Science & Analytics
Machine Learning
Internet of Things
Product Development
Customer Complaints collation
Medical Device Reporting
Unsolicited User Feedback
Maintenance / Service Reports
Device Misuse / Compatibility Issues
PMS Plan
Vigilance & Post Market Safety Reports(PMSR)
Periodic Safety Update Report (PSUR) Services
MDR reporting- 3500A Form
Post Marketing Surveillance
Market Size & Landscape Analysis
KOL Analysis
Price Sensitivity Analysis
Distributor Search and Licensing
Market Access
Physical Testing
Chemical/Biological Testing
Cyber Security Testing and Assessment Services
Testing
Regulatory Intelligence & Strategy, Gap Analysis, Remediation and Submission
Regulatory Affairs
QMS Implementation
ISO 13845 Consulting, 21 CFR
820, SOP Development, Audits
Quality Management
Clinical evaluation reports (MEDDEV 2.7.1)
Clinical investigation protocols and reports
Medical Writing & Medical Review
Clinical Services
Our Services
Case Studies
bottom of page