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 consultancy with over 20 years of experience in medical device and IVD regulation and Quality Assurance, serving organizations of all sizes. They specialize in guiding clients through complex regulatory frameworks.
**Expertise & scope**
* Expertise in European Union's Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746, specifically Article 15 concerning the Person Responsible for Regulatory Compliance (PRRC).
* Services include ensuring conformity assessment procedures, maintaining technical documentation (technical files, design dossiers), and conducting post-market surveillance activities.
* Assistance with UKCA Marking & Technical Files, Medical Device Classification, and UK Responsible Person services.
* Support for navigating regulatory frameworks in key markets including the UK, EU, and the United States.
* Consultancy for CE Marking Medical Devices and understanding if a product is classified as a medical device.
**Reputation / proof points**
* Has served as the UK Responsible Person for over 30 medical device and IVD companies.
* Offers a flat annual fee for UK Responsible Person services with unlimited product registrations.
Patient Guard is a medical device consultancy with over 20 years of experience in medical device and IVD regulation and Quality Assurance, serving organizations of all sizes. They specialize in guiding clients through complex regulatory frameworks.
**Expertise & scope**
* Expertise in European Union's Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746, specifically Article 15 concerning the Person Responsible for Regulatory Compliance (PRRC).
* Services include ensuring conformity assessment procedures, maintaining technical documentation (technical files, design dossiers), and conducting post-market surveillance activities.
* Assistance with UKCA Marking & Technical Files, Medical Device Classification, and UK Responsible Person services.
* Support for navigating regulatory frameworks in key markets including the UK, EU, and the United States.
* Consultancy for CE Marking Medical Devices and understanding if a product is classified as a medical device.
**Reputation / proof points**
* Has served as the UK Responsible Person for over 30 medical device and IVD companies.
* Offers a flat annual fee for UK Responsible Person services with unlimited product registrations.
Additional information
Patient Guard provides tailored regulatory and quality services designed to ensure clients meet their obligations efficiently. Their approach involves clear advice, mapping regulatory frameworks, and guiding clients through the compliance process. They emphasize providing peace of mind that projects are in safe hands. For UK market access, they offer UK Responsible Person services, simplifying the process for non-EU manufacturers and ensuring products comply with UKCA marking regulations. They handle post-market surveillance and vigilance activities, acting as a liaison between manufacturers and authorities.
Key Highlights
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Patient Guard specializes in PRRC services under EU MDR 2017/745 and IVDR 2017/746.
Source
“The Person Responsible for Regulatory Compliance (PRRC) holds a pivotal position. 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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Offers comprehensive support for Technical Files required for CE marking and UKCA marking.
Source
“Medical Devices placed on the European Union (EU) market must comply with the Medical Device Regulations (MDR) EU 2017/745. Similarly, In Vitro Diagnostic Devices (IVD) must adhere to the In Vitro Diagnostic Regulations (IVDR) EU 2017/746. Compliance requires Technical Files to align with Annex I, Annex II, and Annex III of these regulations.”
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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. These companies trust us to ensure their products comply with CE marking and UKCA marking regulations and are properly registered.”
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Possesses 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. We work with all sizes of medical device organisations from start-ups to large corporations.”
Certifications & Trust Signals
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Established consultancy with over 20 years of experience in medical device regulation.
Source
“Being an established medical device consultancy we have developed expertise in all areas of regulation and quality assurance, allowing you to choose just one consultancy that covers all your compliance requirements.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking PRRC services under MDR/IVDR.
- Companies requiring assistance with technical documentation and conformity assessment.
- Organizations needing UK market access via a UK Responsible Person.
How engagement typically works
- Provides clear advice and strategic mapping.
- Offers hands-on guidance throughout the compliance process.
- Acts as a dedicated point of contact for regulatory authorities.
Typical deliverables
- PRRC oversight and compliance assurance.
- Technical file creation and maintenance.
- Conformity assessment support.
- UK Responsible Person services.
- Post-market surveillance and vigilance support.
Good to know
- Best when requiring specialized expertise in EU MDR/IVDR and UK medical device regulations.
Pricing
Model:
Custom pricing
HQ:
Bristol, US
Languages:
English
Timezones:
Europe/London
Claim 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 within a manufacturer's organization responsible for overseeing compliance with regulatory requirements, including conformity assessment, technical documentation, and post-market surveillance.
Regulatory Experience
Over 20 years of experience in medical device and IVD regulation and Quality Assurance.
