Services
Accel Groups is a platform of global seasoned professionals covering different key geographies. We provide the global market entry of your medical devices and In-Vitro Diagnostic (IVD). We provide one-stop solution for the complete product lifecycle including but not limited to: global regulatory strategy, different submission types, device listing and registration, clinical evaluation/clinical studies, quality assurance, post-market surveillance and in-country representation.
- Global Regulatory Strategy
- USA FDA Registration
- China NMPA Registration
- EU MDR/IVDR and CE Registration
- Design Phase Consulting
- Good Manufacturing Practices (GMP)
- Labeling Requirements - 21 CFR Part 801
- Risk Management Consulting - ISO 14971
- Software and Cybersecurity Solutions
- Clinical Strategy
- CRO Services
- Clinical Evaluation Report (CER)
- Clinical Trial Design and Protocol
- Clinical Trial Implementation
- GCP Compliance - ISO 14155
- PMCF Study Design and Implementation
- Medical Writing
- QMS Establishment and Implementation
- Gap Assessment
- ISO 13485 Compliance
- 21 CFR Part 820
- Corrective Action Preventive Action (CAPA) Support
- Internal Audit & Mock Inspection
- MDSAP Support
- PMCF Study Design and Implementation
- Global Post Market Surveillance
- Incident/AE/Recall
- In-country Agent/Person Responsible (PR)/ Authorized Representative
- Design Change Assessment and Submission
- UDI & GUDID
Our 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.
Our Expertise
Aesthetic & Plastic Surgery
Cardiovascular
Combination Products
Dental
Imaging
In-Vitro Diagnostics/CDx
Neurology
Ophthalmology
Orthopedics
Software and AI
Latest News
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.
Global Coverage
We provide comprehensive support to medical device firms pursuing their registration objectives in the following markets:
