Patient Guard
Exact Sciences Corporation
Patient Guard is a Medical Device Regulatory & Quality Assurance Consultancy with over 20 years of experience. They primarily focus on medical device and IVD regulatory services (FDA submissions, QMS, audits, technical files). They are NOT the Cologuard colon cancer screening product (which is made by Exact Sciences). NOTE: Verify if they actually offer cosmetics RP services or if this entry should be removed.
Patient Guard is a well-established Medical Device Regulatory & Quality Assurance Consultancy specializing in medical device and IVD regulatory services including FDA submissions, quality management systems (QMS), audits, biological evaluation, clinical evaluation, technical files, and conformity marking. They are NOT the Cologuard colon cancer screening product (which is manufactured by Exact Sciences). This entry should be verified to confirm if Patient Guard actually offers cosmetics Responsible Person services, or if this entry should be removed from the cosmetics RP directory.
About
**Who they are**
Patient Guard is a Medical Device Regulatory & Quality Assurance Consultancy with over 20 years of experience, offering services for both the EU and UK markets.
**Expertise & scope**
* Specializes in medical device and IVD regulatory services, including FDA submissions, QMS, audits, and technical files.
* Provides UK Responsible Person services for non-EU manufacturers seeking UK market access.
* Offers comprehensive support for CE Mark and UKCA Mark Technical Files, aligning with EU MDR 2017/745 and EU IVDR 2017/746.
* Expertise covers navigating complex regulatory frameworks in the UK, EU, and the United States.
* Services include Auditing Services (ISO 13485, CFR21 part 820, ISO 9001), Biological Evaluation (ISO 10993), and assistance with Product Information Files (PIF) for cosmetics.
**Reputation / proof points**
* Over 20 years of experience in medical device and IVD regulation and Quality Assurance.
* Serves as the UK Responsible Person for over 30 medical device and IVD companies.
* Works with medical device organizations of all sizes, from start-ups to large corporations.
Patient Guard is a Medical Device Regulatory & Quality Assurance Consultancy with over 20 years of experience, offering services for both the EU and UK markets.
**Expertise & scope**
* Specializes in medical device and IVD regulatory services, including FDA submissions, QMS, audits, and technical files.
* Provides UK Responsible Person services for non-EU manufacturers seeking UK market access.
* Offers comprehensive support for CE Mark and UKCA Mark Technical Files, aligning with EU MDR 2017/745 and EU IVDR 2017/746.
* Expertise covers navigating complex regulatory frameworks in the UK, EU, and the United States.
* Services include Auditing Services (ISO 13485, CFR21 part 820, ISO 9001), Biological Evaluation (ISO 10993), and assistance with Product Information Files (PIF) for cosmetics.
**Reputation / proof points**
* Over 20 years of experience in medical device and IVD regulation and Quality Assurance.
* Serves as the UK Responsible Person for over 30 medical device and IVD companies.
* Works with medical device organizations of all sizes, from start-ups to large corporations.
Additional information
Patient Guard emphasizes a tailored approach to regulatory and quality assurance needs, aiming to ensure clients meet all obligations. They offer clear advice, regulatory framework mapping, and process guidance. For UK market access, they provide UK Responsible Person services with a flat annual fee, covering unlimited medical devices or IVD products for registration, with only the MHRA registration fee being additional. They also highlight their expertise in creating and updating Technical Files for medical devices and IVDs, crucial for compliance with EU regulations.
Key Highlights
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Over 20 years of experience in medical device and IVD regulation and Quality Assurance.
Source
“Our experts have over 20 years experience in medical device and IVD regulation and Quality Assurance.”
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Provides UK Responsible Person services for over 30 medical device and IVD companies.
Source
“Patient Guard proudly serves as the UK Responsible Person for over 30 medical device and IVD companies.”
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Offers comprehensive support for CE Mark and UKCA Mark Technical Files.
Source
“Patient Guards consultancy services, staffed by skilled and qualified professionals, offer to create Technical Files for new devices or convert files from the older medical device directives.”
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Expertise covers UK, EU, and FDA regulations.
Source
“Patient Guard specializes in navigating the complexities of regulatory frameworks in key markets, including the UK, EU, and the United States.”
Certifications & Trust Signals
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Established consultancy with offices in the UK and EU.
Source
“Patient Guard Limited; Office Patient Guard Europe UG; Address”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking UK and EU market access.
- Companies needing assistance with regulatory compliance, quality management systems, and technical documentation.
- Businesses requiring a UK Responsible Person or EU Authorised Representative.
How engagement typically works
- Consultative approach with tailored solutions.
- Hands-on support throughout the compliance process.
- Clear advice and strategic planning.
Typical deliverables
- UK Responsible Person services.
- CE Mark & UKCA Mark Technical Files.
- ISO 13485 QMS implementation and auditing.
- Product Information Files (PIF) for cosmetics.
- Biological evaluation reports.
Good to know
- Best when requiring specialized expertise in medical device and IVD regulations.
- Best when needing support for both UK and EU market compliance.
Pricing
Model:
Retainer
HQ:
Blackpool, US
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
EU+UK Cosmetics Compliance
Jurisdictions:
EU, UK
Countries:
GB, IE, FR, DE, NL, ES, IT
Industries:
Cosmetics, Personal care, Beauty
Portfolio:
1-5, 6-25
Onboarding time:
3–10 days
Pricing model:
Retainer
Starting from:
GBP 300
Included services:
Responsible Person role coverage, CPNP notification support, Product Information File (PIF) support, Label review (INCI and mandatory statements), Post‑market compliance and incident escalation
Supports CPNP:
No
Supports PIF:
No
Product Categories:
Cosmetics
Label Review Included:
No
Supports CPSR:
No
Supports Claims Substantiation:
No
Supports Ukcosmetics Rp:
Yes
Can Provide Local Address On Label:
No
Turnaround SLA:
Custom
Additional cosmetics_rp Details
Supports CPNP
No
Supports PIF
Yes
Supports CPSR
No
Markets Covered
EU, UK
Can Provide Local Address On Label
Yes
Label Review Included
No
Onboarding Steps
Arrange a call to discuss needs and how they can help become and remain compliant.
Supports Regulatory Consulting
Yes
Supports Formula Compliance Checks
No
Supports Testing Coordination Management
No
