RegTrac
RegTrac Limited
RegTrac is a global MedTech regulatory partner simplifying compliance across the product lifecycle offering strategy, submissions, QMS and post-market support with a scalable,right-first-time approach
About
**Who they are**<br>RegTrac is a global regulatory and compliance partner dedicated to assisting healthcare and MedTech companies in bringing innovations to market efficiently and with confidence. They focus on simplifying complex regulatory pathways while upholding high standards of quality, safety, and compliance throughout the product lifecycle.<br><br>**Expertise & scope**<br>* Deep domain expertise in regulatory strategy, submissions, quality management systems, clinical and technical documentation, labeling and artwork compliance, and post-market surveillance.<br>* Supports manufacturers from early regulatory strategy through approvals and ongoing compliance.<br>* Operates with a pragmatic, right-first-time approach.<br>* Specializes in operationalizing regulations by combining regulatory intelligence, process rigor, and a collaborative mindset.<br><br>**Reputation / proof points**<br>* Global coverage including UK, EU, CH, US, AU, JP, BR.
Additional information
RegTrac employs a hybrid delivery model that combines hands-on regulatory leadership with efficient execution. This approach allows clients to maintain control over their regulatory strategy while accessing scalable, cost-effective support tailored to their specific products and target markets. Their methodology focuses on enabling healthcare companies to navigate regulatory changes, manage associated risks, and concentrate on delivering safe and effective products to patients worldwide.
Key Highlights
- Global regulatory and compliance partner for healthcare and MedTech.
- Specializes in simplifying complex regulatory pathways.
- Supports the full product lifecycle from strategy to post-market.
- Hybrid delivery model for flexible regulatory support.
Certifications & Trust Signals
- Global coverage including UK, EU, CH, US, AU, JP, BR.
Buyer Snapshot
Best for
- Healthcare and MedTech companies seeking regulatory and compliance partnership.
- Organizations needing to simplify complex regulatory pathways.
- Companies requiring support from early strategy through post-market obligations.
How engagement typically works
- Hybrid delivery model blending leadership with execution.
- Collaborative mindset focused on operationalizing regulations.
- Tailored support based on products and markets.
Typical deliverables
- Regulatory strategy development
- Submission support
- Quality management system implementation
- Clinical and technical documentation
- Labeling and artwork compliance
- Post-market surveillance
Good to know
- Best when clients need to retain control of their regulatory strategy while leveraging external expertise.
HQ:
Woking, United Kingdom
Languages:
English
Timezones:
CET, GMT, US Pacific, IST
Claim status:
Claimed
Services & Capabilities
EU+UK Cosmetics Compliance
Jurisdictions:
Global, UK, EU, CH, US, AU, JP, BR
Countries:
EU-Wide
Industries:
Medical Device & Cosmetics
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, high_portfolio, high_risk_processing, multi_language_support
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 79
Included services:
Documents
Supports CPNP:
Yes
Supports PIF:
Yes
Label Review Included:
Yes
Supports CPSR:
Yes
Supports Regulatory Consulting:
Yes
Supports Formula Compliance Checks:
Yes
Supports Testing Coordination Management:
Yes
Supports Claims Substantiation:
Yes
Supports Ukcosmetics Rp:
Yes
Can Provide Local Address On Label:
Yes
Turnaround SLA:
Custom
eu_ar
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
EU-wide
Industries:
MedicalDevices&Cosmetics
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, ivd, class_iii, high_portfolio, high_risk_processing, multi_language_support, multi_country_coverage, fast_onboarding
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Included services:
RegulatoryDocumentsupport
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
Ireland
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
uk_rp
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global, OTHER
Countries:
UK
Industries:
Medical Device & Cosmetics
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, high_portfolio, high_risk_processing, multi_language_support, multi_country_coverage, fast_onboarding
Response SLA:
Custom hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Included services:
RegulatoryDocumentSupport
Supports GB:
Yes
Supports NI:
Yes
Device Classes Supported:
Class I, Class IIa, Class IIb, IVD, Class III
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
ch_rep
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Swiss
Industries:
Medical Device & Cosmetics
Portfolio:
26-100
Flags:
smd_samd, high_portfolio, multi_country_coverage, implantable, high_risk_processing, fast_onboarding, sterile, measuring, class_iii, ivd, multi_language_support
Response SLA:
hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Included services:
Regulatorydocumentsupport
Device Classes Supported:
Class I, Class III, Class IIa, IVD, Class IIb
Swiss Local Contact:
Yes
Labeling Support:
Yes
Swiss Entity Canton Or Region:
RegTrac GmbH
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
us_agent_fda
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
US
Industries:
Medical Device & Cosmetics
Portfolio:
26-100
Flags:
smd_samd, high_portfolio, multi_country_coverage, implantable, high_risk_processing, fast_onboarding, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA:
Custom hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 78
Included services:
Regulatorydocumentsupport
Product Type:
devices, cosmetics
Annual Renewal Support:
Yes
Registration Support:
Yes
Recall Support:
Yes
Time Zone Coverage:
GMT, CEST, US Mountain, US Central, US Eastern, JST, US Pacific, AEST, CET, IST
Inspection Support:
Yes
Emergency Contact24x7:
Yes
Annual Renewal Reminder:
Yes
prrc_service
Jurisdictions:
EU, UK
Countries:
EU-Wide
Industries:
Medical Device & Cosmetics
Portfolio:
26-100
Flags:
smd_samd, high_portfolio, implantable, high_risk_processing, sterile, measuring, ivd, class_iii, multi_country_coverage, fast_onboarding
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Included services:
Regulatorydocumentsupport.
Named PRRC:
Yes
Availability Hours:
Custom
Device Classes Supported:
Class I, Class Is/Im/Ir, IVD, Class IIa, Class III, Class IIb
PRRC Qualification Summary:
Deep domain expertise and a globally distributed team.
eudamed_reg_support
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
EU-Wide
Industries:
Medical Device & Cosmetics
Portfolio:
26-100
Flags:
smd_samd, high_portfolio, implantable, high_risk_processing, sterile, measuring, class_iii, ivd, multi_language_support, multi_country_coverage, fast_onboarding
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Included services:
Regulatorydocumentsupport
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Certificates, Clinical investigations, Vigilance, Not sure
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
br_local_rep
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Global
Industries:
Medical Device & Cosmetics
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, high_portfolio, high_risk_processing, multi_language_support, multi_country_coverage, fast_onboarding
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Included services:
Regulatorydocumentsupport
Supports Cadastro:
Yes
Supports Registro:
Yes
Portuguese Support:
Yes
Local License Capability:
Yes
Translation Support Ptbr:
Yes
Post Market Support:
Yes
Product Categories Supported:
IVD, Implants, Active devices, Consumables, SaMD, Class IIa, Class I, Software, Class III, Class IIb
tga_sponsor_au
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Australia
Industries:
Medical Device & Cosmetics
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, high_portfolio, high_risk_processing, multi_language_support, multi_country_coverage, fast_onboarding
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Included services:
Regulatorydocumentsupport
Supports Artg:
Yes
Device Classes Supported:
Class I, Class IIb, Class Is/Im/Ir, Class III, Class IIa, IVD
Evidence Review:
Yes
Recall Vigilance Support:
Yes
Fsca Recall Support:
Yes
510k_submission_services
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
US
Industries:
Medical Device & Cosmetics
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, multi_language_support, high_risk_processing, high_portfolio, multi_country_coverage, fast_onboarding
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Included services:
Regulatorydocumentsupport
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Special 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, PMA Strategy & Support, Labeling Review for Submission (510(k)/De Novo/PMA), FDA Meeting Support (Q-Sub / Type C), De Novo Strategy & Authoring, Abbreviated 510(k) Support, Medical Device Reimbursement, 510(k) eSTAR Preparation, Traditional 510(k) Support, Predicate Research & Substantial Equivalence Strategy, Pre-Sub / Q-Sub Preparation, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), De Novo, PMA, Special 510(k), Abbreviated 510(k), Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, SaMD, Other, Combination product
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Years Experience:
8
Ex FDA:
Yes
Ex Notified Body:
Yes
Ex Big Medtech:
Yes
Accepting New Clients:
Yes
Typical Lead Time Weeks:
2
eu_ai_act_gpai_authorized_rep
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Global
Industries:
MedicalDevice&Cosmetics
Portfolio:
26-100
Flags:
smd_samd, high_portfolio, implantable, sterile, measuring, class_iii, ivd, high_risk_processing, multi_language_support, multi_country_coverage, fast_onboarding
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Coverage Window:
Business hours
Service Scope:
Rep + readiness support
Contract Model:
Custom
Languages Supported:
English
eudamed_onboarding_support
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Global
Industries:
Medical Device
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, high_portfolio, high_risk_processing, multi_language_support, multi_country_coverage, fast_onboarding
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 600
Modules Supported:
Actor/SRN, Market Surveillance, UDI/Devices, Certificates
Submission Approach:
Portal, Bulk Submissions
Portfolio Fit:
26-100
Onboarding Speed:
1-2 weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping, Labeling mapping, Access point onboarding
eu_ai_act_high_risk_compliance
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Global
Industries:
Medical Device
Portfolio:
26-100
Flags:
smd_samd, high_portfolio, implantable, high_risk_processing, measuring, sterile, class_iii, ivd, multi_language_support, multi_country_coverage, fast_onboarding
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Delivery Type:
Full readiness package
Delivery Timeline:
custom
Sector Experience:
Medtech
Scope:
Governance, Documentation, Risk management, All-in-one, Conformity support
importer_distributor_compliance
Jurisdictions:
EU, UK, CH, US, BR, AU, OTHER
Countries:
EU UK CH AU BR US UAE
Industries:
Medical Device
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, multi_language_support, high_risk_processing, high_portfolio, fast_onboarding, multi_country_coverage
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Training Available:
Yes
Template Pack Available:
Yes
Deliverables:
SOPs, Templates pack, Training, Ongoing retainer, Audit support
Training Format:
Both
Role Coverage:
Both
jp_mah_dmah
Jurisdictions:
JP, EU, UK, CH, US, AU, BR, Global
Countries:
Japan
Industries:
Medical Device & Cosmetics
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, high_portfolio, high_risk_processing, multi_language_support, multi_country_coverage, fast_onboarding
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Offers MAH:
Yes
Offers DMAH:
Yes
PMDA Support:
Yes
Local License Capability:
Yes
Translation Support:
Yes
GMP Qmssupport:
Yes
Regulatory Liaison PMDA:
Yes
fda_qmsr_transition_inspection_readiness
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Global
Industries:
Medical Device
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, high_portfolio, high_risk_processing, multi_language_support, multi_country_coverage, fast_onboarding
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 79
Service Types:
QMSR/ISO 13485 Gap Assessment, SOP / Documentation Remediation, Design Controls / DHF Modernization, Internal Audit Program Upgrade, Supplier Controls / Quality Agreements, CAPA & Nonconformance Remediation, Mock FDA Inspection, Training & Competency Programs, 483 Response & Remediation Support
Earliest Start:
1_2_weeks
Delivery Mode:
Hybrid
Inspection Experience:
Former FDA investigator on team, Supports mock inspections regularly, ISO 13485 lead auditor capability, MDSAP experience
medical_device_cybersecurity
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
EU UK CH US
Industries:
Medical Device
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, ivd, class_iii, high_portfolio, high_risk_processing, multi_language_support, fast_onboarding, multi_country_coverage
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 150
Provider Type:
Both
Device Types Supported:
Software as a Medical Device (SaMD), Hospital/Enterprise Systems, Connected Hardware (IoT/WiFi/Bluetooth), Other
Pen Testing Available:
No
Threat Modeling Available:
No
Sbom Management Available:
No
Vulnerability Monitoring Available:
No
Rta Rescue Available:
No
medical_device_emc_testing
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Gobal
Industries:
Medical Device
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, multi_language_support, high_risk_processing, high_portfolio, multi_country_coverage, fast_onboarding
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 0
Test Coverage:
Both
Is Accredited:
No
Cb Scheme Support:
No
Pre Scan Debug Support:
No
On Site Testing Option:
No
Wireless Add On Capability:
No
Rush Available:
No
Nda Support:
No
biocompatibility_testing
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Global
Industries:
Medical Device
Portfolio:
26-100
Flags:
smd_samd, high_portfolio, multi_country_coverage, implantable, high_risk_processing, fast_onboarding, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Is Accredited:
No
Glp Compliant:
No
Has In House Toxicology:
No
Rush Available:
No
Nda Support:
No
usability_human_factors_testing
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Global
Industries:
MedicaDevice&Cosmetics
Portfolio:
26-100
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
EUR 78
Usability Study Types Offered:
Both
User Types Supported:
Lay user, Professional healthcare, Both
Use Environments Supported:
Home healthcare, Professional healthcare, Both
Has Participant Recruitment:
Yes
Has Usability Lab:
Yes
Has Remote Testing:
Yes
Is Accredited:
Yes
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
24-48 hours
Rush Available:
Yes
Nda Support:
Yes
Minimum Project Size:
No minimum
Regions Served:
United States, United Kingdom, Canada
sterilization_microbiology_testing
Jurisdictions:
EU, UK, US, CH, AU, JP, BR, Global
Countries:
Global
Industries:
Medical Device
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Sterilization Methods Supported:
Other
Validation Types Offered:
Other
Microbiology Tests Offered:
Other
Is Accredited:
No
GMP Compliant:
No
Glp Compliant:
No
Has In House Sterilization:
No
Has In House Microbiology:
No
Rush Available:
No
Nda Support:
No
packaging_shelf_life_testing
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Global
Industries:
MedicalDeviceandCosmetics
Portfolio:
26-100
Flags:
smd_samd, high_portfolio, implantable, sterile, measuring, class_iii, ivd, high_risk_processing, multi_language_support, fast_onboarding, multi_country_coverage
Response SLA:
24 hours
Onboarding time:
2–6 days
Pricing model:
Custom pricing
Starting from:
EUR 80
Packaging Tests Offered:
Package integrity, Compression, Seal strength, Vibration, Drop, Burst strength, Other
Standards Supported:
ISO 13485, FDA Guidance
Is Accredited:
Yes
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Lead Time Band:
Start in 2-4 weeks
Rush Available:
No
Nda Support:
No
eqms_software_comparison
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Countries:
Global
Industries:
Medical Device and Cosmetics
Portfolio:
26-100
Flags:
smd_samd, implantable, sterile, measuring, class_iii, ivd, multi_language_support, high_risk_processing, high_portfolio, multi_country_coverage, fast_onboarding
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Deployment Model:
Hybrid
Target Company Size:
Mid-market
Modules Included:
Document Control, CAPA, Change Control, Supplier Management, Design Control, Complaint Handling, Audit Management, Risk Management, Training Management, Other
Compliance Standards:
ISO 13485:2016, EU MDR/IVDR, FDA QMSR (21 CFR Part 820), 21 CFR Part 11, ISO 14971, MDSAP, Other
Validation Pack Available:
No
Part11 Support:
No
Implementation Timeline:
1-3 months
Data Migration Support:
Yes
Training Support:
Yes
API Access:
No
Additional cosmetics_rp Details
Supports Regulatory Consulting
Yes
Markets Covered
EU, UK, CH, US, AU, JP, BR
Label Review Included
Yes
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