Maven Professional Services (Template Packs)
Gradle Inc.
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Gradle provides open-source build automation tools and professional services for developers, accelerating software delivery and enhancing productivity. They offer training, support, and consulting for enterprise build infrastructures.
Gradle Inc. is the company behind the popular open-source build system, Gradle Build Tool, which accelerates developer productivity for Java, Android, and Kotlin projects. They offer professional services including training, support, and consulting to help enterprises optimize their build infrastructures and continuous delivery pipelines. With extensive experience in enterprise build environments, Gradle Inc. partners with clients to understand their needs and propose tailored solutions. Their services also extend to build migration, performance profiling, and tooling integrations. Founded in 2010 to meet the growing demand for consulting services, Gradle Inc. has become a critical tool for developers worldwide, with over 50 million downloads per month. They also offer Develocity, a platform providing deep observability, build and test acceleration, and rapid troubleshooting features to support software development at scale.
About
**Who they are**
Maven Professional Services (Template Packs) is a regulatory consulting firm dedicated to assisting medical device manufacturers navigate complex global regulations. Since 2016, they have supported over 300 medical device manufacturers worldwide.
**Expertise & scope**
* Expertise in CE Certification, CE IVD, USFDA Certifications, ISO 13485, MDSAP Certification, and CDSCO Medical Devices Registration.
* Services include Technical File preparation, Clinical Evaluation, Risk Management, General Safety and Performance Requirement (GSPR) documentation, Instruction for Use (IFU), List Of Applicable Standards, Medical Device Testing, Medical Device Labelling, Design History File, and Stability Study.
* Support for In Vitro Diagnostic Devices (IVDs), including Performance Evaluation Report and Technical File for IVDs.
* Global regulatory insight with support across multiple time zones.
**Reputation / proof points**
* Founded in 2016.
* Supported over 300+ medical device manufacturers.
* Clients across multiple time zones.
Maven Professional Services (Template Packs) is a regulatory consulting firm dedicated to assisting medical device manufacturers navigate complex global regulations. Since 2016, they have supported over 300 medical device manufacturers worldwide.
**Expertise & scope**
* Expertise in CE Certification, CE IVD, USFDA Certifications, ISO 13485, MDSAP Certification, and CDSCO Medical Devices Registration.
* Services include Technical File preparation, Clinical Evaluation, Risk Management, General Safety and Performance Requirement (GSPR) documentation, Instruction for Use (IFU), List Of Applicable Standards, Medical Device Testing, Medical Device Labelling, Design History File, and Stability Study.
* Support for In Vitro Diagnostic Devices (IVDs), including Performance Evaluation Report and Technical File for IVDs.
* Global regulatory insight with support across multiple time zones.
**Reputation / proof points**
* Founded in 2016.
* Supported over 300+ medical device manufacturers.
* Clients across multiple time zones.
Additional information
Maven Professional Services (Template Packs) offers tailored regulatory consulting solutions for medical device manufacturers. Their services encompass the creation of essential documentation such as Technical Files, Clinical Evaluations, and Risk Management reports, crucial for CE Marking and USFDA approvals. They also provide guidance on specific regulatory requirements like MDR, IVDR, and Indian Medical Device Rules. The firm emphasizes a personalized approach, adapting to the needs of both agile startups and large corporations, ensuring compliance and supporting business growth.
Key Highlights
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Specializes in CE Marking, CE IVD, and USFDA Certifications.
Source
“Pricing for CE Mark, CE IVD, and USFDA Certifications”
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Offers comprehensive support for Technical Files, Clinical Evaluation, and Risk Management.
Source
“Technical Files for Medical Devices Risk Management for Medical Device General Safety and Performance Requirement (GSPR)”
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Has supported over 300 medical device manufacturers since 2016.
Source
“Since 2016, we’ve proudly supported over 300+ medical device manufacturers for their regulatory requirements around the world.”
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Provides global regulatory insight and support across multiple time zones.
Source
“With clients across multiple time zones, we offer flexibility and support that spans continents.”
Certifications & Trust Signals
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Established in 2016, providing regulatory consulting services.
Source
“Since 2016, we’ve proudly supported over 300+ medical device manufacturers”
Buyer Snapshot
Best for
- Medical device manufacturers seeking global regulatory compliance.
- Companies needing assistance with CE Marking and US FDA submissions.
- Businesses requiring support for IVD regulatory pathways.
How engagement typically works
- Consultative and tailored approach.
- Flexible support across time zones.
- Partnership focused on client growth and innovation.
Typical deliverables
- Technical Files
- Clinical Evaluation Reports
- Risk Management Files
- Regulatory Submission Dossiers
- ISO 13485 Compliance Documentation
Good to know
- Best when requiring specialized expertise in medical device regulations.
Pricing
Model:
Per SKU
Public range:
Publicly listed: Fees range from $6,084 to $24,335 for certain services.
Notes:
Based on publicly listed information; final fees depend on scope and specific device requirements.
“$24,335; $6,084; $9,280”
HQ:
Hollister, USA
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Importer & Distributor Compliance Support
Jurisdictions:
EU, UK
Countries:
GB, IE, DE, FR, NL, BE
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
1-5, 6-25
Onboarding time:
5–20 days
Pricing model:
Per SKU
Starting from:
GBP 600
Included services:
Importer/Distributor SOP & template pack, Compliance gap scan, Audit readiness support
Training Available:
Yes
Template Pack Available:
Yes
Deliverables:
Training
Training Format:
Both
Role Coverage:
Both
Additional importer_distributor_compliance Details
Role Coverage
Importer, Distributor
Device Classes Supported
Class I, IIa, IIb, III
Supports MDR
Yes
Supports IVDR
Yes
Verification Support
Yes
Onboarding Steps
Buyers can initiate contact via a contact form to select their service needs (e.g., CE Certification, US FDA, ISO 13485) and their role. This is followed by a consultation to define requirements and receive a proposal.
Storage Conditions Support
No
