Medical device and IVD regulatory requirements are becoming increasingly complex across the UK, EU, and international markets. Patient Guard provides comprehensive regulatory affairs services to support manufacturers, importers, distributors, and healthcare technology companies throughout the entire product lifecycle.
Our experienced regulatory specialists help organisations achieve and maintain compliance with applicable regulations including EU MDR 2017/745, EU IVDR 2017/746, UK Medical Devices Regulations 2002 (as amended), FDA requirements, ISO 13485, ISO 14971, and other international regulatory frameworks.
Whether you are developing a new medical device, entering a new market, preparing for an audit, or managing post-market obligations, Patient Guard can provide practical and commercially focused regulatory support tailored to your organisation.
Our Regulatory Affairs Services
CE Marking Support
We support manufacturers through the CE marking process for medical devices and IVDs under the EU MDR and IVDR.
Our support includes:
- Medical Device Technical File Development (CE marking against EU MDR 2017/745)
- Medical Device Clinical Evaluation (EU MDR Article 61 and Annex XIV)
- Medical Device Biological Evaluation (ISO 10993-1)
- Medical Device Risk Management (ISO 14971)
- Medical Device Post Market Surveillance (PMS)
- Medical Device Post Market Clinical Follow-up (PMCF)
- Medical Device Person Responsible For Regulatory Compliance (PRRC)
- Medical Device EU Authorised Representative
- IVD Technical File Development (CE marking against EU IVDR 2017/746)
- IVD Performance Evaluation Reports
- IVD Scientific Validation Reports
- IVD Risk Management (ISO 14971)
UK Services
FDA Services
Cosmetic Services
PPE Services
Quality Assurance Services
Why Choose Patient Guard?
Patient Guard has supported over 500 manufacturers and organisations across the medical device, IVD, pharmaceutical, cosmetics, and healthcare sectors.
Our consultants combine practical industry experience with in-depth regulatory knowledge to provide clear, commercially focused guidance.
We support organisations ranging from start-ups and SMEs to multinational manufacturers across a broad range of device technologies and classifications.
Our approach focuses on:
- Practical regulatory solutions
- Clear communication
- Commercial awareness
- Long-term compliance support
- Efficient project delivery
- Audit-ready documentation
Patient Guard operates a BSI certified ISO 13485 Quality Management System, practicing what we preach, our certificate can be viewed or downloaded by clicking on the button below:
Regulatory Expertise Across Global Markets
We support regulatory compliance activities across multiple jurisdictions including:
- European Union (EU MDR & IVDR)
- United Kingdom (UKCA/CE)
- United States (FDA)
- International markets
Industries We Support
Patient Guard supports organisations operating in:
- Medical devices
- In vitro diagnostics (IVDs)
- Software as a Medical Device (SaMD)
- AI healthcare technologies
- Cosmetics
- PPE
- Combination products
- Healthcare technologies
FAQs
What are regulatory affairs services?
Regulatory affairs services help manufacturers achieve and maintain compliance with medical device, IVD, pharmaceutical, and healthcare regulations throughout the product lifecycle.
What regulations apply to medical devices in Europe?
Medical devices placed on the EU market must comply with EU MDR 2017/745, while IVDs must comply with EU IVDR 2017/746.
Do I need a PRRC under MDR or IVDR?
Most manufacturers and authorised representatives operating under the MDR and IVDR are required to appoint a Person Responsible for Regulatory Compliance (PRRC).
Can Patient Guard help with technical documentation remediation?
Yes. We regularly support manufacturers with remediation projects following Notified Body findings, internal audits, or regulatory gap assessments.
Can you support start-up medical device companies?
Yes. Patient Guard supports start-ups and early-stage companies with regulatory strategy, quality systems, technical documentation, clinical evaluation, and market access activities.
Speak With Our Regulatory Specialists
If you require support with regulatory compliance, technical documentation, clinical evaluation, post-market surveillance, or international market access, our team can help.
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