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, specializing in medical device and IVD regulatory services. They offer comprehensive support for navigating complex regulatory frameworks.
**Expertise & scope**
* Expertise in medical device and IVD regulation and Quality Assurance for organizations of all sizes.
* Services include regulatory compliance, product development, quality management, and risk assessment.
* Specialization in UK and EU regulations, including UK Medical Device Regulations 2002, EU MDR 2017/745, and EU IVDR 2017/746.
* Assistance with CE Mark & UKCA Mark Technical Files, including creation and updates.
* Support for UK Responsible Person services for non-EU manufacturers seeking UK market access.
* Auditing services for ISO 13485, CFR21 part 820, and ISO 9001.
* Biological evaluation services for medical devices, including ISO 10993 standards.
* Cosmetics Responsible Person services for the UK and EU markets, including understanding EU Cosmetics Regulation 1223/2009.
**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 organizations ranging from start-ups to large corporations.
Patient Guard is a Medical Device Regulatory & Quality Assurance Consultancy with over 20 years of experience, specializing in medical device and IVD regulatory services. They offer comprehensive support for navigating complex regulatory frameworks.
**Expertise & scope**
* Expertise in medical device and IVD regulation and Quality Assurance for organizations of all sizes.
* Services include regulatory compliance, product development, quality management, and risk assessment.
* Specialization in UK and EU regulations, including UK Medical Device Regulations 2002, EU MDR 2017/745, and EU IVDR 2017/746.
* Assistance with CE Mark & UKCA Mark Technical Files, including creation and updates.
* Support for UK Responsible Person services for non-EU manufacturers seeking UK market access.
* Auditing services for ISO 13485, CFR21 part 820, and ISO 9001.
* Biological evaluation services for medical devices, including ISO 10993 standards.
* Cosmetics Responsible Person services for the UK and EU markets, including understanding EU Cosmetics Regulation 1223/2009.
**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 organizations ranging from start-ups to large corporations.
Additional information
Patient Guard provides tailored regulatory and quality assurance services, aiming to ensure clients meet all compliance obligations. They offer clear advice, regulatory framework mapping, and process guidance. Their approach is designed to provide peace of mind, assuring clients that their projects are managed by experienced professionals. They emphasize a collaborative process, encouraging clients to reach out for calls to discuss how they can assist in achieving and maintaining compliance.
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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Offers Cosmetics Responsible Person services for both UK and EU markets.
Source
“Cosmetics Responsible Person”
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Provides UK Responsible Person services, acting as a liaison for non-EU manufacturers.
Source
“Patient Guard, with a registered office in the UK, offers UK Responsible Person services for non-EU medical device and IVD manufacturers.”
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Assists with the creation and updating of CE Mark & 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.”
Certifications & Trust Signals
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Serves as the UK Responsible Person 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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Works with all sizes of medical device organisations from start-ups to large corporations.
Source
“We work with all sizes of medical device organisations from start-ups to large corporations.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking UK and EU regulatory support.
- Companies needing assistance with technical file creation and updates.
- Businesses requiring a UK Responsible Person for market access.
How engagement typically works
- Collaborative, offering tailored solutions.
- Guidance and support throughout the compliance process.
- Direct communication for project needs.
Typical deliverables
- UK and EU regulatory strategy and advice.
- Technical Files for CE Mark and UKCA Mark.
- Product Information Files (PIF) for cosmetics.
- UK Responsible Person services.
- Auditing reports and QMS documentation.
Good to know
- Best when requiring specialized expertise in medical device and IVD regulations.
- Best when seeking a partner with extensive experience in both UK and EU markets.
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
The process involves reaching out to arrange a call to discuss needs and how Patient Guard can help achieve and maintain compliance. For UKRP services, it involves securing market access within the UK.
