• 510K, IDE, PMA submissions

    Registration of Medical Devices, Food Supplements or Pharmaceuticals in the United States.

  • Access to Markets

    Is your product ready to cross the Borders

  • Active Ingredients

    Searching for the right Ingredients to make health / medical claims

  • Audits

    Does your product & organisation comply with the regulations

  • Authorized Representative

    Need a regulatory responsible person in EU to represent your organisation

  • Biocompatibility & Safety

    Ensure your product meets all Safety Requirements

  • CE Marking

    Registration of Medical Devices in Europe

  • Clinical Support Services

    Expert in Clinical Evaluation both literature and actual studies

  • Due Diligence & GAP Analysis

    Ensure you know the real value and gaps

  • Health Claims

    Products are as successfull as the claims they can make

  • Product Management

    Electronic Common Technical Document, Technical File, Device Master Record, Design History File, Product Information Package

  • Quality Assurance

    ISO 13485, GMP, Post Market Surveillance, Auditing....

  • Quality Management Systems

    Process control during product realization

  • Regulatory Affairs

    Ensures the appropriate licensing, marketing and legal compliance of healthcare products in order to control the safety and efficacy

  • Reimbursements

    Need your product in reimburshement (EU, US, Canada)

  • Risk Management ISO 14971

    Expert in Risk Management

  • Scouting distributors / products

    Need new Products or Distribution partners

  • Strategic Business Solutions

    Organizations today are struggling with the onslaught of complex changes.

  • Training

    Need some training in ISO, Standards, Quality or Regulations

  • U.S. Agent

    FDA U.S. Agent services that meet FDA 21 CFR 807.40 requirements

  • Validation

    Ensure your process is qualified

About PQS group