Mantra Systems
Mantra Systems Ltd
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.
**Expertise & scope**
* UK & EU MDR Consulting
* Medical Device Regulatory Services
* Clinical Evaluation and Complete CEP & CER Writing Services
* IVDR Consulting and In Vitro Diagnostic Regulatory Services
* SaMD Accelerated Approval for time-critical market entry
* Fractional Regulatory Consulting as an extension to your team
* Class I, IIa, IIb, and III Medical Devices support
* Medical Device Software (SaMD) tailored approach
* MDD to MDR Transition for legacy 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.
**Expertise & scope**
* UK & EU MDR Consulting
* Medical Device Regulatory Services
* Clinical Evaluation and Complete CEP & CER Writing Services
* IVDR Consulting and In Vitro Diagnostic Regulatory Services
* SaMD Accelerated Approval for time-critical market entry
* Fractional Regulatory Consulting as an extension to your team
* Class I, IIa, IIb, and III Medical Devices support
* Medical Device Software (SaMD) tailored approach
* MDD to MDR Transition for legacy 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 clinical, regulatory, and medical writing expertise to identify and solve core issues preventing full approval. They bring objectivity and clinical acumen to evidence evaluation, assessing the safety, performance, and benefit-risk profile of medical devices. Their regulatory knowledge and technical writing skills are combined to create compliant submissions that capture the team's expertise.
Key Highlights
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Specializes in CE/UKCA marking, IVDR compliance, and SaMD approvals.
Source
“Mantra Systems offers expert UK & EU medical device regulatory consulting, specializing in CE/UKCA marking, IVDR compliance, and SaMD approvals.”
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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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Offers tailored support for all medical device classes (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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Expertise in MDD to MDR transition for legacy devices.
Source
“MDD to MDR Transition For legacy devices”
Certifications & Trust Signals
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Office located in Sheffield, UK.
Source
“Our head office is based in Sheffield, UK”
Buyer Snapshot
Best for
- Medical device manufacturers seeking UK and EU regulatory compliance.
- Companies needing specialized support for CE/UKCA marking, IVDR, and SaMD.
How engagement typically works
- Fractional regulatory consulting as an extension of the client's team.
- Tailored support based on specific device class and regulatory needs.
Typical deliverables
- CE/UKCA marking strategy and support.
- IVDR compliance documentation.
- SaMD approval submissions.
- Clinical Evaluation Reports (CERs).
- MDD to MDR transition plans.
Good to know
- Best when requiring expert guidance on complex UK and EU medical device regulations.
HQ:
Sheffield, United Kingdom
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, 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 regulatory consulting for medical device manufacturers, applying a unique combination of clinical, regulatory, and medical device expertise. Their team includes clinicians, regulatory medical writers, and specialists with backgrounds in medical device design, clinical evaluation, and technical writing. Dr. Paul Hercock, with a background as a clinician and medical device developer, leads the delivery of their consulting services. Richard Jones brings experience in digital and medical device startups. The team's expertise ensures tailored support for securing UKCA or CE-marking, IVDR approval, and navigating MDD to MDR transitions across all risk classes.
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
The website content does not detail specific onboarding steps, required documents, timelines, or setup procedures.
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
Expertise in medical device regulatory consulting, clinical evaluation, and technical writing.
Regulatory Experience
Experience with UK & EU MDR, IVDR, CE/UKCA marking, SaMD approvals, and MDD to MDR transitions.
