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Quality

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​.

​

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.

Quality

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.

​

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.

Co-Develop

Personalised and Tailored Solutions to Meet Your Needs

Reach out to learn how we can support your medical device journey from inception to market success. 

iDE8 Medical Device Consultancy Outsourced service

Specialist Services & Support for Medical Device Companies.

iDE8 medical device  UKAS AND ISO 13485 CERTIFIED
iDE8 Johnson & Johnson Innovation Winner 2018
iDE8 Top Consultancy 2020 Medical Device

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iDE8 Limited - LifeScience, Medical Device, Contractors Product development.  Copyright © iDE8 Ltd 2024, All rights reserved. 

Company number: SC509285 Registered in Scotland.  VAT Registration Number: 218057321 . ISO13485 Accredited.

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