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 established in 2016, dedicated to assisting medical device manufacturers navigate complex global regulations. They operate with a team of skilled professionals possessing extensive experience in medical device regulatory consulting, quality assurance, and business intelligence.
**Expertise & scope**
* CE Certification
* CE IVD Certification
* USFDA Certifications (including 510k Approval)
* ISO 13485 Consulting
* MDSAP Certification
* Indian Medical Device Rules Registration (CDSCO)
* Technical File preparation for medical devices and IVDs
* Clinical Evaluation Reports
* Risk Management for Medical Devices
* General Safety and Performance Requirement (GSPR) documentation
* Instruction for Use (IFU) and Labelling
* List Of Applicable Standards
* Medical Device Testing
* Design History File
* Stability Study
* UDI Labelling
* EUDAMED Registration
* Country Registrations
**Reputation / proof points**
* Supported over 300+ medical device manufacturers since 2016.
* Operates globally, supporting clients across multiple time zones.
Maven Professional Services (Template Packs) is a regulatory consulting firm established in 2016, dedicated to assisting medical device manufacturers navigate complex global regulations. They operate with a team of skilled professionals possessing extensive experience in medical device regulatory consulting, quality assurance, and business intelligence.
**Expertise & scope**
* CE Certification
* CE IVD Certification
* USFDA Certifications (including 510k Approval)
* ISO 13485 Consulting
* MDSAP Certification
* Indian Medical Device Rules Registration (CDSCO)
* Technical File preparation for medical devices and IVDs
* Clinical Evaluation Reports
* Risk Management for Medical Devices
* General Safety and Performance Requirement (GSPR) documentation
* Instruction for Use (IFU) and Labelling
* List Of Applicable Standards
* Medical Device Testing
* Design History File
* Stability Study
* UDI Labelling
* EUDAMED Registration
* Country Registrations
**Reputation / proof points**
* Supported over 300+ medical device manufacturers since 2016.
* Operates globally, supporting clients across multiple time zones.
Additional information
Maven Professional Services (Template Packs) offers a structured approach to regulatory compliance, emphasizing tailored solutions for medical device manufacturers. Their services encompass the entire lifecycle of regulatory documentation, from initial technical file creation to final market approval. They highlight the importance of clinical evaluation for demonstrating conformity and provide support for various device classes and international regulatory bodies. Engagement typically involves understanding the specific device, its intended use, and the required regulatory pathway to ensure accurate and cost-effective submissions. Their pricing structure is based on project scope, with tentative costs provided for CE certification, and a request for a final proposal after detailed assessment.
Key Highlights
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Established in 2016, with over 300 medical device manufacturers supported.
Source
“Since 2016, we’ve proudly supported over 300+ medical device manufacturers for their regulatory requirements around the world.”
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Expertise 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 and Clinical Evaluations.
Source
“The technical file for medical devices refers to all the documents that a medical device manufacturer has to submit to NB or CA for review & approval for CE certification.”
Certifications & Trust Signals
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Recognized as a trusted medical device regulatory consulting firm.
Source
“We are proud to be recognized as a trusted medical device regulatory consulting firm, known for innovation, precision, and personalized service.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking global regulatory compliance.
- Companies needing assistance with CE Marking, USFDA submissions, and ISO 13485.
How engagement typically works
- Consultative and tailored approach.
- Global support across time zones.
Typical deliverables
- Technical Files
- Clinical Evaluation Reports
- Regulatory Submission Dossiers
- Compliance Strategy Documentation
Good to know
- Best when requiring specialized expertise in medical device regulations.
Pricing
Model:
Per SKU
Public range:
Publicly listed fees include: Fee 1200, Fee 1000, $24,335, $6,084, $9,280.
Notes:
Tentative CE Certification costs are provided, with final proposals dependent on device specifics and intended use.
“Below provided tentative CE Certification cost for various classes. You may need to take our final proposal after considering all variants and Intended use by filling our quote request form online.”
HQ:
Hollister, USA
Languages:
English
Timezones:
Europe/London
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 (implied by CE certification context)
Supports MDR
Yes
Supports IVDR
Yes
Verification Support
Yes
Onboarding Steps
Clients can initiate contact via business enquiry forms or direct communication. Specific service types can be selected, along with the user's role and location.
