Patient Guard
Regulatory affairs and quality assurance consultancy for medical devices and in‑vitro diagnostics. Services include regulatory strategy and submissions for EU/UK/US markets, technical documentation (CE/UKCA) preparation and maintenance, quality management system design and QSR compliance, clinical evaluation and PMCF, authorised/ responsible person representation for EU/UK market access, regulatory auditing, and inspection response support.
Industries
Nr. of Employees
small (1-50)
Products
Online device classification tool (EU MDR)
Web‑based, rule‑based questionnaire that maps device characteristics to EU MDR classification rules to suggest likely device class.
Online device determination tool (EU MDR Article 2)
Web‑based questionnaire to assess whether a product meets the EU MDR definition of a medical device and identify exclusions or borderline cases.
Online device classification tool (EU MDR)
Web‑based, rule‑based questionnaire that maps device characteristics to EU MDR classification rules to suggest likely device class.
Online device determination tool (EU MDR Article 2)
Web‑based questionnaire to assess whether a product meets the EU MDR definition of a medical device and identify exclusions or borderline cases.
Services
End‑to‑end regulatory advice and strategy for device development, submissions and market access across UK, EU and US.
Provision of EU Authorised Representative and UK Responsible Person services, including maintenance of technical files and liaison with authorities for market access.
Preparation and maintenance of technical files and supporting evidence to demonstrate conformity with applicable regulations.
Design and implementation of QMS aligned to ISO 13485 and FDA QSR, including documentation, processes and audit preparedness.
Clinical evaluation planning, literature review, CER preparation, PMCF plan and PMCF reporting to meet regulatory requirements.
Support for PMS systems, vigilance reporting, field safety corrective actions and ongoing risk monitoring.
End‑to‑end regulatory advice and strategy for device development, submissions and market access across UK, EU and US.
Provision of EU Authorised Representative and UK Responsible Person services, including maintenance of technical files and liaison with authorities for market access.
Preparation and maintenance of technical files and supporting evidence to demonstrate conformity with applicable regulations.
Design and implementation of QMS aligned to ISO 13485 and FDA QSR, including documentation, processes and audit preparedness.
Clinical evaluation planning, literature review, CER preparation, PMCF plan and PMCF reporting to meet regulatory requirements.
Support for PMS systems, vigilance reporting, field safety corrective actions and ongoing risk monitoring.
Expertise Areas
- Medical device regulatory strategy and submissions (EU, UK, US)
- Clinical evaluation, CER preparation and PMCF
- Quality management systems and FDA QSR compliance
- EU Authorised Representative / UK Responsible Person market access
Key Technologies
- EU MDR / IVDR regulatory framework
- EUDAMED and national registry submissions
- UKCA / MHRA registration workflows
- ISO 13485 (QMS)
News & Updates
Guidance on assembling and maintaining technical files required under EU MDR 2017/745, focusing on common pitfalls and audit preparedness.
Discussion of risk management as a continuous process that underpins device safety and regulatory success across the lifecycle.
Practical guidance for manufacturers on complying with parallel EU MDR and UK MDR frameworks following regulatory divergence.
Guidance on assembling and maintaining technical files required under EU MDR 2017/745, focusing on common pitfalls and audit preparedness.
Discussion of risk management as a continuous process that underpins device safety and regulatory success across the lifecycle.
Practical guidance for manufacturers on complying with parallel EU MDR and UK MDR frameworks following regulatory divergence.