Patient Guard
Exact Sciences Corporation
Exact Sciences offers Cologuard, a leading non-invasive colon cancer screening test that can be completed at home. They are dedicated to eradicating cancer through early detection and innovative solutions.
Exact Sciences is committed to eradicating cancer through early detection and innovative solutions. Their flagship product, Cologuard, is a leading non-invasive colon cancer screening test that patients can complete in the privacy of their own homes. The company emphasizes the importance of early detection, noting that many colon cancer cases have no family history and that rates are increasing in younger adults. Cologuard is covered by Medicare, most major insurance plans, and is an eligible expense for flexible spending accounts (HSA, HRA, FSA), with 96% of users paying nothing out-of-pocket with insurance. Exact Sciences provides comprehensive support for patients throughout their Cologuard journey, from ordering and using the kit to returning it. They offer customer service in English, Spanish, and many other languages via phone and online resources. The company, also known for its OncoExTra® cancer therapy selection test, is driven by a mission to fight cancer for individuals and families, aiming to detect it earlier when treatment is most effective.
About
**Who they are**
Patient Guard is a medical device regulatory and quality assurance consultancy with over 20 years of experience, serving organizations of all sizes from startups to large corporations.
**Expertise & scope**
* Expertise in navigating complex medical device and IVD regulations across key markets including the UK, EU (MDR 2017/745, IVDR 2017/746), and the United States (FDA).
* Offers Person Responsible for Regulatory Compliance (PRRC) services for EU MDR and IVDR.
* Provides UK Responsible Person (UKRP) services for non-EU manufacturers seeking UK market access.
* Specializes in CE Mark & UKCA Mark technical files, clinical evaluations, and biological evaluations (ISO 10993 series).
* Conducts internal auditing services for ISO 13485, CFR21 part 820, and ISO 9001.
* Offers cosmetic regulatory services for both UK and EU markets, including safety assessments and Product Information File (PIF) maintenance.
**Reputation / proof points**
* Serves as the UK Responsible Person for over 30 medical device and IVD companies.
* Has a registered office in the UK and an office in Europe.
Patient Guard is a medical device regulatory and quality assurance consultancy with over 20 years of experience, serving organizations of all sizes from startups to large corporations.
**Expertise & scope**
* Expertise in navigating complex medical device and IVD regulations across key markets including the UK, EU (MDR 2017/745, IVDR 2017/746), and the United States (FDA).
* Offers Person Responsible for Regulatory Compliance (PRRC) services for EU MDR and IVDR.
* Provides UK Responsible Person (UKRP) services for non-EU manufacturers seeking UK market access.
* Specializes in CE Mark & UKCA Mark technical files, clinical evaluations, and biological evaluations (ISO 10993 series).
* Conducts internal auditing services for ISO 13485, CFR21 part 820, and ISO 9001.
* Offers cosmetic regulatory services for both UK and EU markets, including safety assessments and Product Information File (PIF) maintenance.
**Reputation / proof points**
* Serves as the UK Responsible Person for over 30 medical device and IVD companies.
* Has a registered office in the UK and an office in Europe.
Additional information
Patient Guard emphasizes a tailored approach to regulatory and quality assurance needs, aiming to provide clear advice and map out regulatory frameworks and strategies. They offer support throughout the compliance process, ensuring clients can achieve and maintain compliance with relevant regulations. Their services are designed to streamline regulatory processes, minimize compliance risks, and accelerate market access for medical devices and IVD products. They also highlight their ability to handle Post Market Surveillance (PMS) activities and vigilance, ensuring seamless communication between manufacturers and regulatory authorities.
Key Highlights
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Offers PRRC services compliant with EU MDR 2017/745 and IVDR 2017/746.
Source
“Under the European Union’s Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746 article 15, the PRRC plays a critical role in ensuring adherence to regulatory standards and safeguarding patient safety.”
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Provides UK Responsible Person services 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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Has 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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Specializes in CE Mark & UKCA Mark Technical Files.
Source
“CE Mark & UKCA Mark Technical Files”
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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Offers a flat annual fee for UK Responsible Person services with no hidden costs.
Source
“We offer a flat annual fee for our UK Responsible Person service, with no hidden costs or surprise fees.”
Buyer Snapshot
Best for
- Manufacturers seeking PRRC services under EU MDR/IVDR
- Companies needing a UK Responsible Person for market access
- Organizations requiring comprehensive medical device regulatory consultancy
How engagement typically works
- Hands-on support throughout the compliance process
- Tailored advice and strategic mapping
- Clear communication with regulatory authorities
Typical deliverables
- PRRC appointment and oversight
- UKRP appointment and product registration
- Technical documentation support (CE/UKCA)
- Clinical evaluation reports
- Biological evaluation reports
- Auditing services and QMS support
Good to know
- Best when requiring specialized expertise in EU and UK medical device regulations.
Pricing
Model:
Custom pricing
HQ:
Bristol, US
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
GB, US, DE, FR, EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
1-5
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Starting from:
GBP 1,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
No
Availability Hours:
Extended hours
Device Classes Supported:
IVD
PRRC Qualification Summary:
The PRRC is a designated individual within a medical device manufacturer’s organization responsible for overseeing compliance with regulatory requirements. Their responsibilities encompass various aspects of regulatory compliance, including ensuring conformity assessment, maintaining technical documentation, and conducting post-market surveillance activities. Patient Guard offers comprehensive PRRC services tailored to meet the unique needs of our clients, acting as a liaison between the manufacturer and regulatory authorities.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Engage with Patient Guard to arrange a call to discuss needs and how they can help achieve and maintain compliance.
Coverage Details
PRRC availability set to Business hours with defined escalation path (seed summary).
Device Classes Supported
Class I, IIa, IIb, III (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
Designated individual responsible for overseeing compliance with regulatory requirements under MDR and IVDR.
Regulatory Experience
Over 20 years of experience in medical device and IVD regulation and Quality Assurance, with expertise in UK, EU, and FDA regulations.
