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 extensive experience in regulatory affairs and quality assurance, specializing in guiding medical device and IVD organizations through complex regulations. They offer tailored solutions to ensure clients meet their regulatory and quality obligations.
**Expertise & scope**
* Ensuring adherence to regulatory standards and safeguarding patient safety under the EU's Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
* Overseeing compliance with regulatory requirements, including conformity assessment and maintaining technical documentation.
* Providing comprehensive assistance in regulatory compliance, product development, quality management, and risk assessment.
* Navigating regulatory frameworks in key markets, including the UK, EU, and the United States.
* Specializing in services such as Medical Device Classification, UKCA Marking & Technical Files, and UK Responsible Person (Medical Devices).
**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.
Patient Guard is a medical device consultancy with extensive experience in regulatory affairs and quality assurance, specializing in guiding medical device and IVD organizations through complex regulations. They offer tailored solutions to ensure clients meet their regulatory and quality obligations.
**Expertise & scope**
* Ensuring adherence to regulatory standards and safeguarding patient safety under the EU's Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
* Overseeing compliance with regulatory requirements, including conformity assessment and maintaining technical documentation.
* Providing comprehensive assistance in regulatory compliance, product development, quality management, and risk assessment.
* Navigating regulatory frameworks in key markets, including the UK, EU, and the United States.
* Specializing in services such as Medical Device Classification, UKCA Marking & Technical Files, and UK Responsible Person (Medical Devices).
**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.
Additional information
Patient Guard's PRRC services are crucial for manufacturers needing to comply with the EU's MDR and IVDR. They ensure that medical devices and in vitro diagnostic devices undergo thorough conformity assessment procedures and that technical documentation, such as technical files and design dossiers, accurately reflects the device's characteristics and compliance status. Their expertise extends to addressing regulatory queries, managing updates, and ensuring products meet essential requirements, including safety and performance standards. They also offer support for UKCA marking and technical files, and act as a UK Responsible Person for non-EU manufacturers seeking UK market access.
Key Highlights
-
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.”
-
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.”
-
Expertise in EU MDR 2017/745 and EU 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...”
Certifications & Trust Signals
-
Established medical device consultancy with offices in the UK and EU.
Source
“Patient Guard Limited; Office Patient Guard Europe UG;”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers needing PRRC services.
- Companies seeking to navigate EU MDR and IVDR compliance.
- Organizations requiring assistance with technical documentation and conformity assessment.
How engagement typically works
- Tailored approach to meet specific client needs.
- Providing clear advice and mapping regulatory frameworks.
- Holding clients' hands throughout the compliance process.
Typical deliverables
- PRRC oversight and compliance assurance.
- Conformity assessment support.
- Technical documentation maintenance.
- UK Responsible Person services.
- Medical Device Classification guidance.
Good to know
- Best when clients require expert guidance on EU MDR/IVDR and UKCA 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.
Regulatory Experience
Over 20 years of experience in medical device and IVD regulation and Quality Assurance.
