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Average Ratings 11 Ratings

Total
ease
features
design
support

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 

Screenshots View All

Screenshots View All

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 

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