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)