Quality Assurance & Regulatory Affairs

  • Danilo Bosetti – QA/RA Manager

Team QA

  • Charlotte Costa
  • Claudio Tagliavini
  • Emanuela Govi

Team RA

  • Glauco Gozzi
  • Maria Silvia Meschiari

Team Medicina

  • Caterina Buono
  • Shaista Patel
  • Joanne Schmidt
  • James Snow
  • Maria Ziden

Quality Assurance

Activities

Operating since the first ISO certification of the company, the Quality Assurance office manages the company Quality System: a set of procedures, methods, instructions, and registrations relevant to every process in the company (design, production, purchases, sales, maintenance, movement, training etc.). They are designed to execute processes efficaciously and efficiently, by reducing possibility of error and by guaranteeing that the products satisfy the quality and safety requirements.

The office works with all the other departments and weighs in on the processes, directly or indirectly, by:

  • Promoting a “Quality Culture”
  • Solving problems and flaws of products during the manufacturing stages
  • Management of customer claims
  • • Defining methods, procedures, and operative instructions, updating them as needed
  • • Defining plans and methods for the quality control of products
  • • Qualification and evaluation of Suppliers
  • • Management of audits from Customers, Certifying Agencies, Notified Bodies and Competent Authorities (Health Minister in Italy)
  • • Management of internal audits
  • • Reviewing quality agreements with Customers and Suppliers

Numbers

The HMC Premedical Quality Control System has:

  • 1 Quality Manual
  • 36 Operating Procedures
  • 77 Operating Instructions
  • 120 Attachments and Registration Forms

The HMC Premedical Quality System is ISO certified 13485:2016 by IMQ LTD.

Regulatory Affairs

Activities

The Regulatory Affairs Office is made up of experts in the regulatory framework relevant to the Medical Devices area: they make sure that it is kept up to date and shared with the other departments for the design, production and commercialization of products.

Among our main tasks, we have:

  • Verifying and examining the applicable Laws and Regulations, keeping their evolution constantly updated
  • Supporting all company departments by informing them on the necessary requirements
  • Analyzing the registration requirements of the Medical Devices in the countries of commercialization
  • Preparing the files for registration based on the information supplied by the other departments
  • Preparing the papers required for the CE Certification of Medical Devices
  • Communicating with the Notified Bodies for CE Certification related activities
  • Working with other departments on Medical Devices (Risk Management, General Requirements of Safety and Performance, Post Market Surveillance and Post Market Clinical Follow up, Clinical Evaluation, etc..)

Numbers

HMC Premedical obtained CE authorizations for:

  • 7 Families of I class Medical Devices
  • 15 Families of Is, IIa and IIb class Medical Devices

Besides the CE Certification for the European Community, we also registered Medical Devices in the USA, Mexico, Saudi Arabia, and Australia, and we are currently working on several new countries.

Quality Control

  • Barbara Carnevali
  • Sara El Oudini
  • Roberta Mantovani
  • Marylin Massimo
  • Sara Pettazzoni
  • Elisa Sprocatti

Activities

The Quality Control office plans and executes every control established by the procedures and the technical specifications of the products, in all the stages of manufacturing, from raw materials to finished product, and only releasing it to the next phase if compliant.

Among the tasks of the Quality Control operators are:

  • Checking materials and finished products arriving from other companies
  • Checking the product in every stage of the process: molding, extrusion, automatic and manual assembly, and packaging
  • Releasing the product if it complies to the specifications
  • Identifying and segregating the non-compliant product to make sure it’s unusable
  • Supporting other departments in defining appropriate action to dispose of the non-compliant product
  • Supporting the R&D office in the processes of validation.

To complete these tasks, the Quality Control operators use several measurement tools, such as:

  • A three-dimensional optical measuring system with touch probe
  • Profile projectors
  • An inline measuring system of the pipe diameter
  • A dynamometer for traction and compression checks
  • Peel Force Test equipment for packaging
  • Leakage under pressure testing equipment (up to 8 bars)
  • Digital calipers, micrometers, calibrated spines, Luer ISO 80369-7 swabs, and ENFit ISO 80369-3 swabs

Numbers

As Quality control, we check and release an average of 100 lots a day, which adds up to 23.000 lots a year, of raw materials, components, and finished medical devices. We sample a representative number of items for every lot, and we do:

  • Paperwork check
  • Dimensional checks
  • Functional checks
  • Visual checks