Our mission is to be your partner in MedTech, guiding you through the challenges and complexities of growing your business. We provide hands on advisory and execution services for your clinical, compliance and business needs.
Clinical Services:
- Clinical trail design, planning & execution
- Medical writing
- Post market clinical studies
(Healthcare/ Medical Device) Compliance Services:
- MDR 2017/745 Technical documentation writing and reviewing
- IEC 62304 Medical device software
- IEC 60601 Medical electrical equipment
- ISO 13485: 2016 Implementation and audits
- MDSAP Implementation and audits
- ISO 14155 Clinical investigations and evaluations
- ISO 42001 Artificial Intelligence Management System (AIMS)
- ISO 27001 Information & Cyber security
- UKCA Compliance
- CAPA Management and hands-on support
- Audit preparation
- Independent 3rd party audits
- Audit outcome implementation
- Interim QA/ RA support
Business consulting services:
- Investment readiness
- (Independent) Business review & recommendations for VC or PE funds
- Hands-on go to market support
- Interim (CxO) positions
- Special projects
Cybersecurity for Medical Devices and Software:
- IEC 81001-5-1
- MDCG 2019-16 r1
- FDA Cybersecurity guidelines
- Pen testing
Company Details
- Employees
- 1
- Founded
- -
- Address
- High Tech Campus, 5,netherlands
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Keywords
- Medical Device, Software development, ISO 13485, ISO 27001, Ophthalmology, Urology, Imaging, Radiation Oncology, Business Due Dilligence, Medical Device Regulations, IEC 60601, ISO 10993, ISO 14155, ISO 14971, UKCA Compliance, Clinical Studies, Clinical Strategy, Software Development, MedTech cybersecurity, IEC 81001, MDCG 2019-16, Post market clinical studies.
- HQ
- Eindhoven, North Brabant
Innovation Dynamics Bv Questions
Innovation Dynamics Bv's website is http://www.innovation-dynamics.com
Innovation Dynamics Bv's LinkedIn profile is https://nl.linkedin.com/company/innovation-dynamics-bv
Innovation Dynamics Bv has
1 employees.
View email and phone details for 1
employees at Innovation Dynamics Bv.
Innovation Dynamics Bv's industry is
Business Consulting and Services
Innovation Dynamics Bv's top competitors are
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Innovation Dynamics Bv's categories are Business Consulting and Services
Innovation Dynamics Bv's founding year is 2024
