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 & 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 solving core issues that prevent full approval.
**Expertise & scope**
* UK & EU MDR Consulting
* Medical Device Regulatory Services
* Clinical Evaluation & Complete CEP & CER Writing Services
* IVDR Consulting
* 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
* Class I, Class IIa & IIb, and Class III Medical Devices support
**Reputation / proof points**
* Office based in Sheffield, UK
Mantra Systems provides expert UK & 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 solving core issues that prevent full approval.
**Expertise & scope**
* UK & EU MDR Consulting
* Medical Device Regulatory Services
* Clinical Evaluation & Complete CEP & CER Writing Services
* IVDR Consulting
* 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
* Class I, Class IIa & IIb, and Class III Medical Devices support
**Reputation / proof points**
* Office based in Sheffield, UK
Additional information
Mantra Systems tailors its services to manufacturers, leveraging a background in medical device design to understand product features and risks. Their team combines clinical, regulatory, and medical writing expertise to provide objective assessments of safety, performance, and benefit-risk profiles. They focus on creating compliant submissions that capture the team's expertise, aiming to simplify the regulatory approval process.
Key Highlights
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Specializes in UK & EU medical device regulatory consulting.
Source
“Mantra Systems offers expert UK & EU medical device regulatory consulting”
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Expertise in CE/UKCA marking, IVDR compliance, and SaMD approvals.
Source
“specializing in CE/UKCA marking, IVDR compliance, and SaMD approvals.”
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Provides tailored support for all medical device classes.
Source
“They provide tailored support for all device classes”
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Offers Fractional Regulatory Consulting as an extension to your team.
Source
“Fractional Regulatory Consulting An extension to your team when you need it”
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
- Manufacturers seeking UK & EU medical device regulatory support
- Companies needing assistance with CE/UKCA marking and IVDR compliance
- Businesses requiring SaMD approvals or market access programs
How engagement typically works
- Fractional consulting as an extension of your team
- Tailored support for specific device classes and regulatory challenges
Typical deliverables
- CE/UKCA marking strategies
- IVDR compliance plans
- Clinical Evaluation Reports (CERs)
- Quality Management System (QMS) implementation
Good to know
- Best when requiring specialized expertise in UK and EU medical device regulations.
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 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. Sandra Gopinath and Dr. Gayle Buchel contribute subject matter expertise, objectivity, and clinical acumen to their writing team.
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
Expert UK & EU medical device regulatory consulting, combining clinical, regulatory, and medical device expertise.
Regulatory Experience
Expertise in UK & EU medical device regulations, CE/UKCA marking, IVDR compliance, SaMD approvals, and market access.
