
Support Through Outsourced Expertise
At iDE8, we offer a full suite of services tailored to accelerate your medical device development and ensure compliance with the highest industry standards. From concept to market entry and beyond, our expertise and bespoke solutions are designed to meet your unique needs and drive succes
Quality Management
Our Quality Management Support focuses on four essential components: Planning, Assurance, Control, and Improvement. We provide a holistic approach to sustain and enhance quality across your organization.
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Our support is not just a one-time solution but a continuous cycle that assures ongoing excellence within your business.
Software Quality
With a deep understanding of diverse e-QMS environments, we tailor our services to meet your specific needs and platform, providing comprehensive support that covers implementation, optimization, compliance, and ongoing management.
Our goal is to streamline your quality processes, making them more efficient and compliant with regulatory standards, while also being flexible enough to adapt to the ever-evolving landscape of our industry.
Document Control
Simplify your document control process with iDE8's dedicated team. We understand the importance of every detail and work as an extension of your quality department, ensuring accurate and efficient document management for your medical device company.We are recognized internationally as Subject matter system experts and advanced users within global world-leading enterprise quality management systems.
Audit Support
Our Medical Device Auditing Solutions act as your independent quality assurance, ensuring compliance and mitigating risks. We streamline the auditing process, enabling you to focus on healthcare innovation with confidence.
If you’d like more information about our features, get in touch today.
SERVICE
OUR
Looking to enhance your device quality while reducing costs?
Our comprehensive Quality Management solutions streamline processes and ensure compliance, significantly saving you on quality-related expenses.
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At IDE8, we deliver exceptional quality through comprehensive outsourced expertise. With over 120 years of combined experience, we provide complete outsourced quality department solutions, ensuring top quality and compliance standards.
We offer tailored quality management services that streamline operations, reduce costs, and speed up time-to-market
OUTSOURCING
INCLUDES:
Complete Quality Dept
Project Management
Total eQMS Functionality
Training Management
Continuous Process Improvement
Fixed Monthly Fee
Why Outsource to Us?
120+ Years Quality Experience
Expertise and reliability in every project.
Latest Insights
Cutting-edge knowledge and best practices to every QMS.
Personalised
Service
Bespoke Quality systems meet your business demands.
Rapid Value Creation
Drive swift cost savings and value generation through our service.
DIGITAL MANAGEMENT
e-QMS SUPPORT
With a deep understanding of diverse e-QMS environments, we tailor our services to meet your specific needs and platform, providing comprehensive support that covers implementation, optimization, compliance, and ongoing management.
Our goal is to streamline your quality processes, making them more efficient and compliant with regulatory standards, while also being flexible enough to adapt to the ever-evolving landscape of our industry.
DATA INTEGRITY
Assessing risk to data integrity and making recommendations to ensure data accuracy and consistency across a system's lifecycle.
e-QMS MANAGEMENT
Supporting your Quality Management Teams in the day-day operations and management of your EQMS.
Software V&V
Providing support with validation lifecycle activities to prove that your system works in its intended environment​.
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Gap Analysis
Conducting gap analyses of your systems against regulatory requirements, with recommendations on how to address gaps.
CLOUD VALIDATION
(IaaS, PaaS, SaaS)
Validation Support of cloud-based systems, ensuring compliance to International regulations.
21 CFR Part 11 Compliance
Provide guidance in ensuring your electronic records and signatures are considered to be trustworthy and equivalent to paper records.
WORKFLOW MANAGEMENT
We work with you to author validation documents. From Defining requirements, To providing templates, quality reviewing and remediation.
Configuration Management
Working with you to Define strategies for handling changes systematically so that a system maintains its integrity over time.
SOFTWARE SUPPLIER AUDITS
Carrying out audits on vendors of software and systems and providing documentation to support your validation strategy and demonstrate regulatory compliance.
VALIDATION MANAGEMENT
Supporting you in the development of compliant approach's to your computer system validation.
Spreadsheet Validation
Verifying the reliability of your spreadsheet and its output for its intended use.
SUPPORT
AUDIT
Our Medical Device Auditing Solutions act as your independent quality assurance, ensuring compliance and mitigating risks. We streamline the auditing process, enabling you to focus on healthcare innovation with confidence.
AUDIT MANAGEMENT
Helping simplify and well-organise the workflow and collaboration process of compiling audits.
SUPPLY CHAIN AUDITS
Working with your supply chain per the Supplier Quality Agreement, ensuring compliance with relevant regulatory requirements, regulations and standards.
INSPECTION READY
We can help you get ready for inspection. We offer a proactive process of 'getting ready' for an inspection by a regulatory authority (such as FDA).
INTERNAL AUDITS
Performed by a qualified Lead Auditor, from within your organisation who is independent of the activities being audited.
AUDIT FACILITATION
Effective Audit facilitation is a crucial part of any audit process. We conduct goal-oriented communications, mediation and negotiation with and between the process partners who are to be audited.
REMEDIATION
Supporting your stakeholders to effectively address and resolve observations and findings raised.
OUR
APPROACH
We prioritize a collaborative approach, working closely with you to identify key areas for outsourcing that align with your strategic goals.
Our service is flexible, and designed to scale with your business, ensuring you always have access to the expertise and capabilities you need.
ALIGNMENT
We work with you to identify core versus non-core activities, ensuring resources are optimized for maximum impact.
FLEXIBILITY
Our solutions are scalable and adaptable, designed to meet your evolving business needs.
EXPERTISE
Gain access to specialized skills and exclusive technologies, enhancing your competitive edge without the overhead of in-house development.
EFFICIENCY
With tools like our e-QMS Genitsys, we ensure seamless integration and real-time collaboration, enhancing quality control and operational efficiency.

OUTSOURCED
BENEFITS
Reduce your OPEX and increase your team's, capacity, and capability.
Allowing you to grow faster.
Operational Efficiency & Cost Effectiveness
Outsourcing your quality functions to iDE8 means you can focus on your core competencies. We provide scalable subscription packages. With a Fixed Monthly fee that flexes with your needs. Eliminate internal overhead costs and administrative burdens of an in-house quality team.
Seamless Integration & Real-Time Oversight
We are an extension of your company, integrating seamlessly into your operations. With transparent, real-time oversight of quality processes, you have the information you need to make informed decisions about product quality.
Regulatory Compliance & Continuous Improvement
Our team of seasoned professionals stays abreast of ever-changing regulations, ensuring compliance, and driving continuous quality improvements. This results in enhanced product reliability and increased customer satisfaction, reducing non-compliance risks.
PER YEAR
COST SAVINGS
Quality Outsourcing Savings for Startups and Scale-ups:
Every penny and day counts in the world of startups and scale-ups. Our outsourcing services are designed to match your need for speed and efficiency, offering substantial operational and capital expense savings.
By partnering with us, you gain access to a world of external expertise and cutting-edge solutions, freeing you from the cost and complexity of building in-house capabilities. This means you can focus on what you do best, driving innovation and growth, while we ensure your quality needs are met with precision and agility.
Quality Function/Sub-Function | Estimated Savings in CAPEX (%) | Estimated Savings in OPEX (%) |
---|---|---|
Software Quality Assurance | 40% | 35% |
Standards Management | 35% | 30% |
Document Control | 40% | 35% |
Complaints Management | 25% | 30% |
Quality Audits | 30% | 30% |
Supplier Quality Management | 35% | 30% |
Training and Development | 20% | 25% |
*Cost savings will vary depending on the maturity of your quality processes and size of business.
Unlock the agility and efficiency your business demands. Our specialized outsourcing services are the perfect fit for startups and scale-ups looking to navigate the complexities of quality management without the hefty investment in in-house capabilities.
Let's propel your innovation further, faster, and more cost-effectively.
Get Your Customized Quote Now - Discover how our outsourcing solutions can be tailored to your unique needs, helping you achieve breakthrough growth without the burden of quality management overheads.
Quality Outsourcing Savings for Corporates:
For established corporations, the balance between maintaining in-house capabilities and leveraging external efficiencies is crucial. Our outsourcing services offer a strategic approach to optimize your quality functions, achieving cost savings while ensuring the highest standards of quality and compliance.
With our services, corporates can supplement their existing capabilities with our specialized expertise, focusing on core strategic activities while we handle the complexities of quality management. This selective outsourcing model allows you to maintain control over critical functions while still reaping the benefits of reduced operational and capital expenditures.
Quality Function/Sub-Function | Estimated Savings in CAPEX (%) | Estimated Savings in OPEX (%) |
---|---|---|
Software Quality Assurance | 35% | 30% |
Standards Management | 30% | 25% |
Document Control | 30% | 25% |
Complaints Management | 15% | 20% |
Quality Audits | 25% | 25% |
Supplier Quality Management | 30% | 20% |
Training and Development | 10% | 15% |
*Cost savings will vary depending on the maturity of your quality processes and size of business.
Streamline your operations and reinforce your market leadership with strategic outsourcing.
If you're looking to optimize your existing quality management processes, enhance efficiency, and maintain strategic control, we're here to offer our expertise and advanced solutions.
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Request Your Strategic Consultation Today - Learn how our tailored outsourcing services can complement your in-house capabilities, offering you the perfect blend of control and cost savings, ensuring your organization remains at the forefront of quality and innovation.
DOCUMENT
CONTROL
Simplify your document control process with iDE8's dedicated team. We understand the importance of every detail and work as an extension of your quality department, ensuring accurate and efficient document management for your medical device company.
We are recognized internationally as Subject matter system experts and advanced users within global world-leading enterprise quality management systems.
CHANGE MANAGEMENT
Creating and processing your changes within your quality systems.
COMPLAINTS SUPPORT
Processing and analysis of incoming complaints into the organisation.
DOCUMENT ADMIN
Reviewing, collaborating and processing all documents within your system.
STANDARDS MANAGEMENT
Supporting your technical reviewers and regulators with the processing and management of standards.
DHF/DMR MAINTENANCE
Working across your departments to maintain critical quality files.
Supporting your Quality Management Teams in the day-day operations and management of your EQMS.
MANAGEMENT
QUALITY
Our Quality Management Support focuses on four essential components: Planning, Assurance, Control, and Improvement. We provide a holistic approach to sustain and enhance quality across your organization.
​
Our support is not just a one-time solution but a continuous cycle that assures ongoing excellence within your business.
Management Reviews
From planning to facilitation and action remediation, we work with your team as a Quality management reps.
Supplier Management
Working with your internal team and supply chain to support incoming goods and product quality.
Process Quality
Process quality is important for every business.
We help you measure and improve processes so that you release the best products.
Risk Management
Working with you on the assessment, control, communication, and review of quality risks.
Product Realisation
Working with you across the entire product life cycle from conception to completion.
Project Management
Helping you successfully manage quality projects for medical device products with our custom-tailored project management services.
Cost of Quality
Working across all 4 pillars to appraise, identify and reduce costs.
Training Management
Helping you track, train and ensure compliance with all required policies and procedures.
Non-conformity /
CAPA Management
Reducing the frequency and impact of nonconformances in terms of cost and resources and improve product/service quality and QMS effectiveness.
Statistical Analysis
Statistics support for process control, and product performance to monitor the quality of your products.
Complaints Management
Handling complaints that is systematic and orderly. To resolve issues while creating a positive impact.
Continuous improvement
Supporting your quality department in incremental and breakthrough improvements of products, services or processes.
Quality system Design
Bespoke quality system Implementation aligned to organisational goals and complaint to ISO 13485 and 21 CFR PART 820
SOFTWARE
QUALITY
We understand software's critical role in the functionality and reliability of medical devices, which is why we employ a rigorous, quality-centric approach to every project. Our commitment to enhancing the quality of medical software goes beyond mere compliance.
At the heart of our mission lies a dedication to exceeding standards and driving innovation in healthcare technology. With an unwavering focus on precision and excellence, our expert team provides customized software quality support tailored to the unique needs of each medical device.
Data Integrity
Assessing risk to data integrity and making recommendations to ensure data accuracy and consistency across a system's lifecycle.
Risk Management
Assessing system risks and providing recommendations for a risk-based approach to validation activities.
Software V&V
Providing support with validation lifecycle activities to prove that your system works in its intended environment​.
​
Gap Analysis
Conducting gap analyses of your systems against regulatory requirements, with recommendations on how to address gaps.
CLOUD VALIDATION
(IaaS, PaaS, SaaS)
Validation Support of cloud-based systems, ensuring compliance to International regulations.
21 CFR Part 11 Compliance
Provide guidance in ensuring your electronic records and signatures are considered to be trustworthy and equivalent to paper records.
Lifecycle Documentation
We work with you to author validation documents. From Defining requirements, To providing templates, quality reviewing and remediation.
Configuration Management
Working with you to Define strategies for handling changes systematically so that a system maintains its integrity over time.
SOFTWARE SUPPLIER AUDITS
Carrying out audits on vendors of software and systems and providing documentation to support your validation strategy and demonstrate regulatory compliance.
Validation Strategy & Management
Supporting you in the development of compliant approach's to your computer system validation.
Spreadsheet Validation
Verifying the reliability of your spreadsheet and its output for its intended use.
SUPPORT
OUR
We work with you across all components of Continuous improvement to day-day administration.
SYSTEM EVALUATION
Regular, comprehensive assessments to identify improvement areas and ensure alignment with industry advancements.
COMPLIANCE REINFORCEMENT
Proven methodologies for continuous optimization of compliance processes, mitigating risks of penalties.​
PEx CULTIVATION
Lean and process mapping methodologies to streamline operations, reduce waste, and foster continuous quality improvement
PROCESS ENHANCEMENT
Pre-emptive approach using Kaizen events for continuous improvements, keeping your systems at the industry's forefront
IMPROVEMENT STRATEGY
Data-driven approaches tailored for optimizing processes, reducing waste, and enhancing product quality.
SIX SIGMA TRAINING
Comprehensive training empowering your team to effectively implement and manage Six Sigma methodologies, instilling a culture of quality and process excellence.
CULTURE DEVELOPMENT
Equip your team with the necessary tools to foster a quality-centric mindset at every level.
DOCUMENTATION IMPROVEMENT
Advanced techniques for identifying gaps and implementing enhancements, promoting efficient systems and improved compliance.