Apurva Joshi
★★★★★
1.2
/ 5
•
3,294 reviews
RAC-certified Regulatory Affairs professional with 7+ years of global experience in Class I, II, and III medical devices and IVDs, including software-enabled and digital medical devices.
About
**Who they are**
Apurva Joshi is a RAC-certified Regulatory Affairs professional with over 7 years of global experience, specializing in medical devices and IVDs across Class I, II, and III, including software-enabled and digital medical devices.
**Expertise & scope**
* Regulatory affairs for Class I, II, and III medical devices and IVDs.
* Experience with software-enabled and digital medical devices.
* Global coverage including the EU, UK, US, and Switzerland.
* Fluent in English.
**Reputation / proof points**
* RAC-certified Regulatory Affairs professional.
Apurva Joshi is a RAC-certified Regulatory Affairs professional with over 7 years of global experience, specializing in medical devices and IVDs across Class I, II, and III, including software-enabled and digital medical devices.
**Expertise & scope**
* Regulatory affairs for Class I, II, and III medical devices and IVDs.
* Experience with software-enabled and digital medical devices.
* Global coverage including the EU, UK, US, and Switzerland.
* Fluent in English.
**Reputation / proof points**
* RAC-certified Regulatory Affairs professional.
Additional information
For buyers seeking regulatory representation in Switzerland, understanding the specific requirements for medical devices and IVDs is crucial. Apurva Joshi's expertise spans various device classes and includes digital health solutions. The provider's global experience, particularly with EU, UK, and US markets, offers a broad perspective for international clients navigating Swiss regulations. Engagement typically involves clear communication and a focus on compliance with relevant standards.
Key Highlights
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RAC-certified Regulatory Affairs professional.
Source
“RAC-certified Regulatory Affairs professional”
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Over 7 years of global experience in medical devices and IVDs.
Source
“7+ years of global experience in Class I, II, and III medical devices and IVDs”
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Expertise includes software-enabled and digital medical devices.
Source
“including software-enabled and digital medical devices”
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Coverage across EU, UK, US, and Switzerland.
Source
“Coverage: EU, UK, US, CH”
Certifications & Trust Signals
- RAC (Regulatory Affairs Certification)
- Experience at major MedTech companies (Olympus, Waters)
- Direct experience with FDA, Health Canada, and EU Notified Bodies
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking Swiss representation.
- Companies with software-enabled or digital medical devices.
- Businesses requiring global regulatory support (EU, UK, US).
How engagement typically works
- Direct communication for project needs.
- Review of experience and recommendations.
Typical deliverables
- Regulatory affairs support.
- Compliance guidance for medical devices and IVDs.
- Representation for Swiss market access.
Good to know
- Best when requiring expertise in Class I, II, and III devices.
Facts
Examples & Achievements
* Successfully authored and submitted multiple Traditional and Special 510(k)s for Class II software-enabled electrosurgical and lithotripsy systems.
* Led the EU MDR transition and technical file submission for a lithotripsy device.
* Developed a Regulatory Change Assessment Template that improved review cycle time.
* Managed global registrations across diverse markets including APAC and LATAM.
* Authored over 5 Clinical Evaluation Reports (CERs) for Class I & II devices under EU MDR and MEDDEV 2.7/1 Rev 4.
* Led the EU MDR transition and technical file submission for a lithotripsy device.
* Developed a Regulatory Change Assessment Template that improved review cycle time.
* Managed global registrations across diverse markets including APAC and LATAM.
* Authored over 5 Clinical Evaluation Reports (CERs) for Class I & II devices under EU MDR and MEDDEV 2.7/1 Rev 4.
More about our services
Services are tailored to meet the specific needs of medical device and IVD manufacturers, from startups to established corporations. This includes end-to-end support for U.S. market entry, from initial Pre-Submission strategy to final 510(k) clearance. For companies targeting the EU, I provide guidance on MDR/IVDR transition, technical file remediation, and Notified Body interactions. My specialized focus on software and cybersecurity ensures that your digital health products meet the latest global standards, including IEC 62304.
HQ:
Natick, US
Languages:
English
Timezones:
America/New_York
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
EU, UK, US, CH
Countries:
US
Industries:
Medical Devices, IVD
Flags:
smd_samd, sterile, measuring, class_iii, ivd, high_risk_processing, high_portfolio, multi_country_coverage, fast_onboarding
Included services:
Pre-Submission Strategy, 510(k) Preparation, FDA Communication
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Special 510(k) Support, 510(k) eSTAR Preparation, Traditional 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, PMA Strategy & Support, De Novo Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, Combination product, SaMD
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
No
Years Experience:
8
Num510k Submitted:
4
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Accepting New Clients:
Yes
medical_device_cybersecurity
Jurisdictions:
EU, UK, CH, US
Countries:
US, CA
Industries:
Medical Devices, IVD
Flags:
smd_samd
Included services:
Regulatory Strategy, Documentation Support
Provider Type:
Service Firm
Submission Stage Support:
Pre-Submission (Planning), Ready for 510(k)/MDR Submission, RTA Fix (FDA Refusal Response)
Device Types Supported:
Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth), Hospital/Enterprise Systems
Pen Testing Available:
No
Threat Modeling Available:
No
Sbom Management Available:
No
Vulnerability Monitoring Available:
No
Rta Rescue Available:
No
cosmetics_rp
Jurisdictions:
EU, UK, CH, US
Supports CPNP:
No
Supports PIF:
No
Label Review Included:
No
Supports CPSR:
No
Supports Regulatory Consulting:
No
Supports Formula Compliance Checks:
No
Supports Testing Coordination Management:
No
Supports Claims Substantiation:
No
Supports Ukcosmetics Rp:
No
Can Provide Local Address On Label:
No
eu_ar
Jurisdictions:
EU, UK, CH, US
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, Class IIb, Class Is/Im/Ir, Class III, Class IIa, IVD
Post Market Support:
Yes
Labeling Review:
Yes
Can Be Named On Label:
No
Vigilance Contact Support:
No
Fsca Recall Support:
No
uk_rp
Jurisdictions:
EU, UK, CH, US
Response SLA:
hours
Supports GB:
No
Supports NI:
No
Device Classes Supported:
Class I, Class III, Class IIa, IVD, Class IIb
MHRA Support:
No
Can Be Named On Label:
No
MHRA Portal Support:
No
Vigilance Support:
No
ch_rep
Jurisdictions:
EU, UK, CH, US
Response SLA:
hours
Device Classes Supported:
Class I, Class III, IVD, Class IIa, Class IIb
Swiss Local Contact:
No
Labeling Support:
No
Can Be Named On Label:
No
Vigilance Contact Support:
No
prrc_service
Jurisdictions:
EU, UK, CH, US
Named PRRC:
No
Device Classes Supported:
Class I, Class IIb, Class Is/Im/Ir, Class III, Class IIa, IVD
PRRC Qualification Summary:
RAC-certified Regulatory Affairs professional with 7+ years of global experience.
fda_qmsr_transition_inspection_readiness
Jurisdictions:
EU, UK, CH, US
Countries:
US
Industries:
Medical Devices, IVD
Flags:
smd_samd
Included services:
QMS Gap Analysis, Procedure Updates, Audit Support
Service Types:
QMSR/ISO 13485 Gap Assessment, CAPA & Nonconformance Remediation, Training & Competency Programs, Supplier Controls / Quality Agreements, SOP / Documentation Remediation, Design Controls / DHF Modernization, Internal Audit Program Upgrade, 483 Response & Remediation Support
Additional 510k_submission_services Details
Services Offered
FDA 510(k) Submission Services
Pathways Supported
510(k)
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