ReguLogix Consulting Ltd
ReguLogix Consulting Ltd specialises in helping innovative start-ups and SMEs navigate the complex world of regulatory and quality assurance. With expertise across a wide range of products— from Medical Devices, IVDs (In Vitro Diagnostics), and Drug-Device Combinations to Software, AI, AR/VR as Medical Devices— we deliver tailored, cost-effective solutions that simplify compliance and accelerate market readiness.
Our services include comprehensive support in quality assurance and regulatory affairs as well as robust guidance on Data Protection Regulations, AI Act Compliance, PRRC, UK Authorised Representative services, and others. From crafting regulatory strategies to preparing technical documentation and developing QMS, we ensure your project is on track at every stage. Additionally, our consultancy covers critical areas such as risk management, vigilance, due diligence, performance evaluations, clinical and usability studies, and more.
SERVICES OFFERED
1. Quality Assurance Services
Implementation and Maintenance of Quality Management Systems
- What it means: Creating and maintaining a structured system that ensures products consistently meet quality standards and regulatory requirements
- What we do, for example:
- Assess current processes and identify gaps
- Create necessary documentation (policies, procedures, work instructions)
- Set up systems for document control and record-keeping
- Establish processes for product testing and validation
- Implement complaint handling and feedback systems
- Create training programs for staff
- Set up systems to track and improve product quality
Audit Support and Preparation
- What it means: Helping prepare for and pass inspections by regulatory authorities or certification bodies
- What we do, for example:
- Conduct mock audits to identify potential issues
- Train staff on how to interact with auditors
- Prepare and organise documentation
- Support during actual audits as expert representatives
- Help address any findings or concerns raised during audits
- Create action plans for implementing improvements
Quality Agreements
- What it means: Creating legally binding documents that define quality expectations between organisation and suppliers/partners
- What we do, for example:
- Draft agreements that protect the company’s interests
- Define roles and responsibilities
- Establish quality standards and testing requirements
- Set up communication protocols
- Define how to handle quality issues
- Create processes for changes and approvals
Training Programs
- What it means: Ensuring your team understands and can implement quality requirements
- What we do, for example:
- Develop custom training materials
- Conduct workshops and training sessions
- Create competency assessment tools
- Establish ongoing training schedules
- Maintain training records
2. Regulatory Affairs Services
Strategic Regulatory Planning
- What it means: Creating a roadmap for getting your product approved for sale in target markets
- What we do, for example:
- Analyse product to determine its classification
- Identify applicable regulations and standards
- Determine testing requirements
- Create a timeline for submissions
- Estimate costs and resources needed
- Identify potential challenges and solutions
Technical Documentation Preparation
- What it means: Creating the required documentation that proves the product is safe and effective
- What we do, for example:
- Compile product descriptions and specifications
- Document design and development processes
- Gather and organise test results
- Create risk management files
- Prepare clinical evaluation protocols
- Prepare human usability testing protocols
- Ensure documentation meets specific market requirements
Pre-market Submissions
- What it means: Preparing and submitting applications to get approval to sell the product
- What we do, for example:
- Prepare submission documents
- Compile supporting data
- Submit applications to authorities
- Respond to questions from reviewers
- Track submission progress
- Maintain submission records
Post-market Surveillance
- What it means: Monitoring product's performance after it's on the market
- What we do, for example:
- Set up systems to collect user feedback
- Monitor and analyse complaints
- Track adverse events
- Prepare safety reports
- Manage product updates and changes
- Handle communication with authorities
3. Specialised Services
DTAC (Digital Technology Assessment Criteria) Support
- What it means: Helping to meet NHS requirements for digital health technologies
- What we do, for example:
- Assess technology against DTAC criteria
- Prepare required documentation
- Support clinical safety case development
- Help with data protection impact assessments
- Guide you through the NHS approval process
Person Responsible for Regulatory Compliance (PRRC)
- What it means: Acting as a legally required regulatory expert for EU compliance
- What we do, for example:
- Verify product compliance
- Monitor quality system performance
- Report incidents to authorities
- Keep technical documentation updated
- Ensure proper product testing
- Maintain regulatory registrations
MedTech Due Diligence
- What it means: Assessing the regulatory and quality aspects of medical technology companies
- What we do, for example:
- Review existing approvals and certificates
- Assess quality system compliance
- Evaluate technical documentation
- Review clinical data
- Identify potential compliance issues
- Estimate costs for remediation
Clinical Evaluation Support
- What it means: Helping you prove your product is safe and performs as intended
- What we do, for example:
- Plan clinical investigations
- Prepare study protocols
- Create data collection forms
- Monitor study progress
- Prepare clinical evaluation reports
Products and services
Quality Assurance and Regulatory Affairs Consultancy
SERVICES OFFERED
1. Quality Assurance Services
Implementation and Maintenance of Quality Management Systems
- What it means: Creating and maintaining a structured system that ensures products consistently meet quality standards and regulatory requirements
- What we do, for example:
- Assess current processes and identify gaps
- Create necessary documentation (policies, procedures, work instructions)
- Set up systems for document control and record-keeping
- Establish processes for product testing and validation
- Implement complaint handling and feedback systems
- Create training programs for staff
- Set up systems to track and improve product quality
Audit Support and Preparation
- What it means: Helping prepare for and pass inspections by regulatory authorities or certification bodies
- What we do, for example:
- Conduct mock audits to identify potential issues
- Train staff on how to interact with auditors
- Prepare and organise documentation
- Support during actual audits as expert representatives
- Help address any findings or concerns raised during audits
- Create action plans for implementing improvements
Quality Agreements
- What it means: Creating legally binding documents that define quality expectations between organisation and suppliers/partners
- What we do, for example:
- Draft agreements that protect the company’s interests
- Define roles and responsibilities
- Establish quality standards and testing requirements
- Set up communication protocols
- Define how to handle quality issues
- Create processes for changes and approvals
Training Programs
- What it means: Ensuring your team understands and can implement quality requirements
- What we do, for example:
- Develop custom training materials
- Conduct workshops and training sessions
- Create competency assessment tools
- Establish ongoing training schedules
- Maintain training records
2. Regulatory Affairs Services
Strategic Regulatory Planning
- What it means: Creating a roadmap for getting your product approved for sale in target markets
- What we do, for example:
- Analyse product to determine its classification
- Identify applicable regulations and standards
- Determine testing requirements
- Create a timeline for submissions
- Estimate costs and resources needed
- Identify potential challenges and solutions
Technical Documentation Preparation
- What it means: Creating the required documentation that proves the product is safe and effective
- What we do, for example:
- Compile product descriptions and specifications
- Document design and development processes
- Gather and organise test results
- Create risk management files
- Prepare clinical evaluation protocols
- Prepare human usability testing protocols
- Ensure documentation meets specific market requirements
Pre-market Submissions
- What it means: Preparing and submitting applications to get approval to sell the product
- What we do, for example:
- Prepare submission documents
- Compile supporting data
- Submit applications to authorities
- Respond to questions from reviewers
- Track submission progress
- Maintain submission records
Post-market Surveillance
- What it means: Monitoring product's performance after it's on the market
- What we do, for example:
- Set up systems to collect user feedback
- Monitor and analyse complaints
- Track adverse events
- Prepare safety reports
- Manage product updates and changes
- Handle communication with authorities
3. Specialised Services
DTAC (Digital Technology Assessment Criteria) Support
- What it means: Helping to meet NHS requirements for digital health technologies
- What we do, for example:
- Assess technology against DTAC criteria
- Prepare required documentation
- Support clinical safety case development
- Help with data protection impact assessments
- Guide you through the NHS approval process
Person Responsible for Regulatory Compliance (PRRC)
- What it means: Acting as a legally required regulatory expert for EU compliance
- What we do, for example:
- Verify product compliance
- Monitor quality system performance
- Report incidents to authorities
- Keep technical documentation updated
- Ensure proper product testing
- Maintain regulatory registrations
MedTech Due Diligence
- What it means: Assessing the regulatory and quality aspects of medical technology companies
- What we do, for example:
- Review existing approvals and certificates
- Assess quality system compliance
- Evaluate technical documentation
- Review clinical data
- Identify potential compliance issues
- Estimate costs for remediation
Clinical Evaluation Support
- What it means: Helping you prove your product is safe and performs as intended
- What we do, for example:
- Plan clinical investigations
- Prepare study protocols
- Create data collection forms
- Monitor study progress
- Prepare clinical evaluation reports