Our tailored services for Medtech start-ups
PLG provides full product lifecycle support, from Design to Post Market, of Medical Devices, Combined Devices and SaMDs.
We at ProductLife Group have a thorough understanding of Business processes, enabling us to manage communication between the different stakeholders involved in a project – such as clinical, regulatory, quality, PMS team, manufacturing, and commercial – and advise clients on their processes or redefining and formalizing their processes.
Global Strategy
Regulatory
Device Qualification
Device Classification
Development Plan / Regulatory Go-To-Market Strategy
Related to targeted claims and market: integrating regulatory / guidelines requirements / IP / markets / populations & claims
Gap Analysis
Date due diligence: Pre-Clinical / Clinical / Quality / Regulatory / IP
Market Access Strategy
Market Access
- HTA, Pricing & Reimbursement per country (P&R dossier, Budget Impact Model, etc.)
Marketing & commercial
- Product promotion, KOL, Hospital collaboration
Product Development
Preclinical & Clinical – Design
- Designing a development plan including: early feasibility studies, Pediatric Investigation Plan, First-in-human trials
- Clinical / Performance Evaluation (MDR/IVDR)
- Combined products
- Management of scientific advice meeting with targeted regulatory agency
- Real-World Evidence generation strategy
Preclinical & Clinical – Operational
- Lab/CRO selection & management: protocol development, oversight of all the activities managed by the CRO (responsibilities & SOPs), ensuring GLP / CGP and applicable regulatory guidance compliance
Safety Clinical
- Resp. Person, Medical writing, Plan, Reports, Databases, Case management
Manufacturing & Distribution Scheme
- Manufacturing strategy, GMP, CDMO selection & MAT
Compliance
Quality Compliance
- ISO 13485 compliance, Agile QMS and cloud QMS, Risk management ISO 14791, SAMD ISO 62304, Cybersecurity, Ethics for AI, etc.
Regulatory Affairs & Operations
Notified Body Support
- First conformity assessment and Periodic vigilance support
Device Registration
- MDR/IVDR compliance CE marking
- 510(k) compliant FDA approval
We support innovative medtech's
An IVD blood test, supported by SW
- Full support to implement Quality and Regulatory framework documents to access the market
Flash Radiation Therapy
- Support the whole process to obtain the CE marking as Class IIb medium to high-risk medical device for compliance with the MDD/MDR
Bone care system
- Assessment of the QMS needs for a medical device and draft of TCF
- Implementation support of the QMS following the Risk based approach
- Full team providing with a complete PM of all activities needed
- Full industrialized package support, implementing the QMS, releasing TCF, implementing the SW documentation during the entire lifecycle
Auto-injector
- QMS assessment and final closure of TCF
- Risk management (ISO 14971) assessment
- Registration support within Europe (and UK)
- Full team providing with a complete PM of all activities needed (PMS, PMCF, PSUR)
In addition to our portfolio of services, we have packaged specific Innovative solutions that mix the different drivers of our strategy in off-the-shelf processes and tools that enable to bring data intelligence to the regulatory intelligence delivered to our customers.
See in this video a snapshot of solutions we bring in the Medtech domain.