Mantra Systems
Mantra Systems Ltd
Verified
Mantra Systems offers expert UK & EU medical device regulatory consulting, specializing in CE/UKCA marking, IVDR compliance, and SaMD approvals. They provide tailored support for all device classes and transitions.
Mantra Systems provides specialized regulatory consulting services to help medical device manufacturers navigate the complexities of UK and EU compliance. They focus on securing UKCA or CE-marking, ensuring IVDR approval for in vitro diagnostic devices, and accelerating market entry for Software as a Medical Device (SaMD). With a team of experienced clinicians, regulatory medical writers, and device developers, Mantra Systems offers a unique blend of expertise to identify and solve core issues preventing full approval. They deliver tailored support for all device classes (Class I, IIa, IIb, III), including MDD to MDR transitions, and offer fractional consulting as an extension of your team. Their services encompass Clinical Evaluation Reports (CER) and CEP writing, with a proven track record of successful submissions. Mantra Systems is committed to simplifying the regulatory process, ensuring quality devices reach the market efficiently and compliantly.
About
**Who they are**
Mantra Systems provides expert UK and EU medical device regulatory consulting, specializing in CE/UKCA marking, IVDR compliance, and SaMD approvals. They offer tailored support for all device classes and transitions, focusing on identifying and solving core issues that prevent full market approval.
**Expertise & scope**
* UK & EU MDR Consulting
* Medical Device Regulatory Services
* Clinical Evaluation and Complete CEP & CER Writing Services
* IVDR Consulting for In Vitro Diagnostic Regulatory Services
* SaMD Accelerated Approval for time-critical market entry
* US to EU Market Access Programme, leveraging FDA approvals
* QMS Jumpstart for Quality Management Systems
* Fractional Regulatory Consulting as an extension to your team
* Targeted approaches for Class I, Class IIa & IIb, and Class III Medical Devices
**Reputation / proof points**
* Office located in Sheffield, UK
Mantra Systems provides expert UK and EU medical device regulatory consulting, specializing in CE/UKCA marking, IVDR compliance, and SaMD approvals. They offer tailored support for all device classes and transitions, focusing on identifying and solving core issues that prevent full market approval.
**Expertise & scope**
* UK & EU MDR Consulting
* Medical Device Regulatory Services
* Clinical Evaluation and Complete CEP & CER Writing Services
* IVDR Consulting for In Vitro Diagnostic Regulatory Services
* SaMD Accelerated Approval for time-critical market entry
* US to EU Market Access Programme, leveraging FDA approvals
* QMS Jumpstart for Quality Management Systems
* Fractional Regulatory Consulting as an extension to your team
* Targeted approaches for Class I, Class IIa & IIb, and Class III Medical Devices
**Reputation / proof points**
* Office located in Sheffield, UK
Additional information
Mantra Systems tailors its services to manufacturers, leveraging their background in medical device design to understand product features and risks. Their team combines regulatory knowledge, technical writing skills, and clinical acumen to create compliant submissions. They focus on delivering regulatory consulting directly to the manufacturer, rather than through a rigid application of rules, ensuring a practical and effective approach to compliance challenges.
Key Highlights
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Specializes in CE/UKCA marking, IVDR compliance, and SaMD approvals.
Source
“specializing in CE/UKCA marking, IVDR compliance, and SaMD approvals.”
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Offers tailored support for all medical device classes (Class I, IIa, IIb, III).
Source
“Class I Medical Devices A targeted approach for lower-risk devices Class IIa & IIb Medical Devices Supporting medium-risk devices Class III Medical Devices Advanced approach to higher-risk devices”
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Provides Fractional Regulatory Consulting as an extension to your team.
Source
“Fractional Regulatory Consulting An extension to your team when you need it”
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Assists with US to EU Market Access by leveraging FDA approvals.
Source
“US to EU Market Access Programme Leveraging FDA approvals to accelerate EU access”
Certifications & Trust Signals
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Office based in Sheffield, UK.
Source
“Our head office is based in Sheffield, UK”
Buyer Snapshot
Best for
- Manufacturers seeking UK and EU medical device regulatory support
- Companies needing assistance with CE/UKCA marking and IVDR compliance
- Organizations requiring support for SaMD approvals
How engagement typically works
- Tailored support for specific device classes
- Fractional consulting as an extension of the client's team
- Problem-solving focused on core approval issues
Typical deliverables
- CE/UKCA marking strategies
- IVDR compliance plans
- SaMD approval support
- Clinical Evaluation Reports (CER)
- Quality Management System (QMS) implementation
Good to know
- Best when manufacturers require expert guidance on complex regulatory pathways.
HQ:
Sheffield, United Kingdom
Website:
mantrasystems.com
Public email:
contact@mantrasystems.com
Phone:
+44(0)114 299 8889
Languages:
English
Timezones:
Europe/London
Access:
Verified
Claim status:
Listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
GB, EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
6-25
Onboarding time:
5–21 days
Pricing model:
Retainer
Starting from:
GBP 1,800
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
PRRC Qualification Summary:
Mantra Systems offers comprehensive regulatory consulting services for medical device manufacturers. Their team comprises experienced professionals with backgrounds in clinical practice, medical device design, regulatory affairs, and technical writing. They specialize in navigating complex regulations such as UK & EU MDR and IVDR, providing tailored support for CE-marking and UKCA-marking. Services include Clinical Evaluation (CEP & CER writing), SaMD Accelerated Approval, US to EU Market Access, QMS Jumpstart, and Fractional Regulatory Consulting. The company emphasizes a practical, issue-solving approach rather than a dry application of rules, leveraging a unique combination of clinical, regulatory, and medical device expertise to drive product traction alongside approval. Key personnel include Paul Hercock (clinician and medical device developer), Richard Jones (digital platforms and critical business systems), and Sandra Gopinath (regulatory knowledge and technical writing skills).
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 their experienced team to discuss support needs for medical device approval journeys.
Coverage Details
PRRC availability set to Extended hours with defined escalation path (seed summary).
Device Classes Supported
Class I, Class IIa, Class IIb, Class III
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
Expert UK & EU medical device regulatory consulting, specializing in CE/UKCA marking, IVDR compliance, and SaMD approvals. Offers tailored support for all device classes and transitions. Combines clinical, regulatory, and medical device expertise.
Regulatory Experience
Not explicitly stated in years, but expertise covers UK & EU MDR, IVDR, SaMD, CE/UKCA marking, and market access programs.
