Average Ratings 0 Ratings
Average Ratings 11 Ratings
Description
The PeakAvenue Platform stands as an advanced, web-based Software as a Service (SaaS) system aimed at optimizing the entire product lifecycle with remarkable effectiveness. By merging features from e1ns, Quality Center, XERI, and Isograph into one cohesive platform, it empowers users to choose from various specialized applications and methodologies that suit their unique requirements. The platform streamlines the digital transformation of the product lifecycle, providing tools such as a communication hub, connectivity options, quality assurance loops, a structured Failure Mode and Effects Analysis (FMEA), processes for capturing lessons learned, and enhanced visibility into the supply chain. Utilizing cutting-edge web and cloud technologies, PeakAvenue simplifies the onboarding process for new employees through browser-based access, accommodates flexible scaling for personnel, methods, and applications, and offers reliable hosting for software updates and deployment. Furthermore, it maintains rigorous IT security measures and can incorporate artificial intelligence functionalities as needed, making it a versatile choice for organizations aiming to enhance their operational efficiency. This comprehensive approach not only streamlines workflows but also encourages continuous improvement across the product lifecycle.
Description
qmsWrapper is a connected Quality Management System (eQMS) built for medical device startups and SMEs. It helps organizations move from paper forms, Word documents, and spreadsheets to a scalable, AI-enabled QMS that grows with their business through Foundation, Lifecycle, and Vigilance. Designed for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects documents, quality events, risk, training, CAPA, technical documentation, and traceability in one platform.
Best For:
- Medical device and SaMD companies implementing or modernizing an ISO 13485 QMS.
- Startups and SMEs that want to grow from controlled documents to connected quality workflows without replacing their QMS.
API Access
Has API
No
API Access
Has API
No
Integrations
Jira
No
Meta Ads
Yes
OpenText ALM Quality Center
Yes
PLATO XERI
Yes
PLATO e1ns
Yes
Integrations
Jira
Yes
Meta Ads
No
OpenText ALM Quality Center
No
PLATO XERI
No
PLATO e1ns
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
No
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
PeakAvenue
Country
Germany
Website
www.peakavenue.com/software/peakavenue-platform
Vendor Details
Company Name
qmsWrapper
Country
Canada
Website
www.qmswrapper.com
Product Features
Engineering
2D Drawing
No
3D Modeling
No
Chemical Engineering
No
Civil Engineering
No
Collaboration
No
Design Analysis
No
Design Export
No
Document Management
No
Electrical Engineering
No
Mechanical Engineering
No
Mechatronics
No
Presentation Tools
No
Structural Engineering
No
Quality Management
Audit Management
No
Complaint Management
No
Compliance Management
No
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
No
Document Control
No
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No
Product Features
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
No
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
Yes
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes