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


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


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

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


  • 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)