Global One-stop Solution
for Medical Devices/IVD Market Access:
RA, QA, CRO, Commercialization
Our Services
Complete product life cycle management
MARKET ACCESS
Discover unaddressed market needs, assess market sizing and feasibility, clinical KOL feedback, reimbursement and commercial partners etc. READ MORESTRATEGY PLANNING AND DESIGN REVIEWING
Determine comprehensive regulatory and clinical strategy for the whole market access process.
GLOBAL REGULATORY
For your targeted countries: classification, regulatory and clinical pathway, technical documents preparation, QMS, submission, agent listing and in-country representation etc. READ MORECRO
Evaluate the necessary clinical requirements for your product and create a clinical strategy. READ MOREQUALITY ASSURANCE
Work on establishing and sustaining an efficient Quality Management System (QMS) that complies with ISO 13485 and local regulations. READ MOREPOST MARKET SURVEILLIANCE
Sustain your market presence through our global surveillance support, incidents/AE/recall reporting, annual reporting, etc.
SUPPLIER QUALIFICATION & AUDIT
Evaluate and audit the suppliers to ensure the quality, safety, and compliance of medical devices throughout their production and distribution. READ MOREOur Services
Complete product life cycle management
MARKET ACCESS
Discover unaddressed market needs, assess market sizing and feasibility, clinical KOL feedback, reimbursement and commercial partners etc.
DESIGN & VALIDATION PREPARATION
Design planning/applicable standards, documentation of design/development process
GLOBAL REGULATORY
For your targeted countries: classification, regulatory and clinical pathway, technical documents preparation, QMS, submission, agent listing and in-country representation etc.
CRO
Evaluate the necessary clinical requirements for your product and create a clinical strategy.
QUALITY ASSURANCE
Work on establishing and sustaining an efficient Quality Management System (QMS) that complies with ISO 13485 and local regulations.
POST MARKET COMPLIANCE
Sustain your market presence through our global surveillance support, incidents/AE/recall reporting, annual reporting, etc.
SUPPLIER QUALIFICATION & AUDIT
Evaluate and audit the suppliers to ensure the quality, safety, and compliance of medical devices throughout their production and distribution.
Global Coverage
Global focus and complete product life cycle management
Integrated Resource & Learning Center
Where Experts Meet Knowledge
Expertise & Team
Our team of subject matter experts cover your complete product life cycle needs across key geographies from preclinical discovery, product design and validation documentation, QMS regulatory affairs, clinical research, QMS/GMP and cybersecurity etc. We are here to accelerate your key countries market access with one-stop solution.
Aesthetic & Plastic Surgery
Cardiovascular
Combination Products
Dental
Imaging
In-Vitro Diagnostics/CDx
Neurology
Ophthalmology
Orthopedics
Software and AI
Latest Updates
September 510K Clearance Highlights
Accel Groups select ten medical devices or in vitro diagnostic reagents from the monthly 510(k) clearance list (five from Chinese manufacturers and five from foreign manufacturers) for brief introductions.
Roche Launches Test Kit for Detecting 12 Respiratory Viruses
Roche’s TAGS technology enables simultaneous detection of 12 respiratory viruses, including influenza A, influenza B, respiratory syncytial virus (RSV), and COVID-19.
FDA Updates Patient Preference Guidance to Cover Product Lifecycle
On September 4, the FDA released a draft guidance that significantly revises its previous guidance on the use of voluntary patient preference information (PPI) in medical devices, shifting the focus from the premarket stage to the entire product lifecycle.
August FDA Clearance Highlights
Accel Groups select ten medical devices or in vitro diagnostic reagents from the monthly 510(k) clearance list (five from Chinese manufacturers and five from foreign manufacturers) for brief introductions. This aims to provide the latest global updates on medium and low-risk devices or reagents.
