Speak with a Regulatory Expert
Get expert support with EU MDR, IVDR, UKCA, cosmetics, PPE and global regulatory compliance. Tell us about your product or project, and one of our specialists will contact you within 24 hours.
How can we help you?
Select the area most relevant to your product or regulatory needs.
Medical Devices
EU MDR and UKCA support
In Vitro Diagnostics (IVD)
IVDR and FDA 510(k) support
Cosmetics
EU and UK cosmetic compliance
Personal Protective Equipment (PPE)
EU and UK PPE compliance
Quality Assurance
ISO 13485, ISO/IEC 27001 ISO 9001 support
FDA Submissions
US regulatory strategy and submissions
Request a Quote or Book a Consultation
Tell us about your product and regulatory requirements, and one of our specialists will contact you within 24 hours.
Why contact Patient Guard?
2. A specialist contacts you within 24 hours
3. We arrange a consultation if needed
4. You receive clear next steps
Book a free 30-minute consultation with one of our regulatory experts.
Book a Free ConsultationRequest a Quote or Speak with a Regulatory Expert
Tell us about your product and regulatory requirements, and one of our specialists will contact you within 24 hours.
Our Locations
Patient Guard Ltd
Lancaster House Amy Johnson Way, Blackpool, Lancashire, FY2 4RP. United Kingdom
Company Registration Number: 10654752
Patient Guard Europe UG (haftungsbeschränkt)
Hauffstraße 41, 73765, Neuhausen, Deutschland (Germany)
Company Registration Number: HRB 779309
Frequently Asked Questions (FAQs)
Do you offer a free consultation?
Yes, we offer an initial consultation to understand your regulatory requirements and recommend the best next steps.
How quickly will you respond?
We aim to respond to all enquiries within 24 hours.
What information should I provide?
You can provide as much or as little information as you have. Helpful details include your product type, target market, and the support you need.
Do you work with start-ups?
Yes, we support start-ups, SMEs and multinational manufacturers across a wide range of regulated product categories.
Can you support both UK and EU compliance?
Yes, we provide support for both UK and EU regulatory requirements, including authorised representative and responsible person services.
News from Patient Guard
ISO 14971 Risk Management Implementation Guide
Medical devices exist to improve health outcomes, but every device carries potential risk. Managing those risks in a structured, documented, and defensible way is essential for regulatory approval and patient safety.
Clinical Evaluation Report: EU MDR Requirements
Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
Medical Device Labelling Requirements Explained
Medical device labelling is more than a packaging exercise. It is a regulatory requirement that communicates essential information about a device’s identity, safety, and intended use.
Medical Device Post-Market Surveillance Guide
Regulatory approval is not the end of scrutiny, it is the beginning of structured data collection.
ISO 13485:2016 Requirements & Implementation Guide
If you are implementing a medical device QMS, preparing for certification, or recovering from audit findings, understanding ISO 13485:2016 requirements is non-negotiable.
IVDR Transitional Provisions: 2026 Milestones
2026 represents a significant milestone for the amended IVDR transitional provisions framework.
