Comedical

Manufacturing medical devices for over 30 years

Production

TOXICOLOGY SOLUTIONS

Divided into three main groups, Comedical series of products for the assay of drugs of abuse and markers of alcohol abuse (EtG) in hair represents the most innovative system available in the world to manage this type of analysis in clinical and forensic laboratories:

VMA Line®, M3 Line® and TricoCheck Line®

Together, they represent a real program that meets the needs of any laboratory and treatment service interested in the screening of drugs in hair.

MEDICAL SOLUTIONS

Comedical’s COGEL, ECG, EEG and gels for ultrasound and physiotherapy are daily used by doctors, technicians and physiotherapists.

The products are characterized by stability, certified biocompatibility, high quality of the raw materials, optimized formulations that enable production to be carried out for third-party companies.

COMPLIANCE WITH EUROPEAN LAWS

Each Comedical product is manufactured and marketed in compliance with the strict European laws that regulate the production and sale of Medical Devices, In Vitro Diagnostics and chemical substances in general.

Quality and certifications

QUALITY POLICY

In Comedical’s laboratories we design, test and manufacture extraction reagents, analytical methods and in vitro diagnostics for clinical and forensic use, for the detection and quantification of drugs of abuse and medicines in human biological matrices: hair and body hair, nails, blood, oral fluid and urine.

Comedical also designs and places on the market containers for the collection and storage of biological samples, and manufactures in its own plant medical devices in the form of conductive gels for diagnosis and therapy.

Alongside its products, Comedical provides qualified technical and application support that assists customers in the use of its methods. Through the continuous renewal of company policies and targeted investment in people, technologies and facilities, the company intends to consolidate its position of reference on the national and international market in clinical and forensic toxicology and in medical devices.

Scope

Comedical maintains a single quality management system, certified to UNI EN ISO 9001:2015 and UNI CEI EN ISO 13485:2021, for the following activities:

Design, production and placing on the market of physical conductors in the form of liquid, gel and paste. Design, production and placing on the market of in vitro diagnostics for the analysis of drugs of abuse in biological matrices. Design, production management and placing on the market of containers for the collection and storage of biological samples. Distribution and servicing of breathalysers, within the scope of UNI EN ISO 9001:2015 only.

The system applies to all the activities listed, carried out at the operating unit in via della Cooperazione 29, Trento, and to all products manufactured and placed on the market. Outsourced processes, including production by third parties, remain under the control of the system.

As a manufacturer of medical devices and in vitro diagnostic medical devices, and as a distributor of the breathalysers it markets, Comedical undertakes to:

Compliance with requirements

  • comply with Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, and subsequent amendments;
  • apply the relevant national provisions, harmonised standards and common specifications, taking into account the guidance of the Medical Device Coordination Group;
  • maintain the CE marking of its devices, with notified body certification where the risk class requires it;
  • manage product risk throughout the entire life cycle, in accordance with UNI CEI EN ISO 14971;
  • carry out post-market surveillance and fulfil vigilance obligations, including the reporting of serious incidents and field safety corrective actions;
  • ensure the availability of the person responsible for regulatory compliance required by Article 15 of the two regulations;
  • offer products and services that meet both customer requirements and those laid down by applicable laws and regulations.

Customers and interested parties

  • keep in mind that the reference point for the entire way the company operates is and will remain the customer, understood in the broadest sense;
  • continuously monitor the context in which it operates, in order to identify the needs and expectations of customers and other interested parties;
  • consistently measure and improve customer satisfaction;
  • maintain a high degree of flexibility in manufacturing and supply, in order to respond to specific customer requests.

Risks, opportunities and improvement

  • identify, assess and manage the risks and opportunities that may affect company performance;
  • maintain certification of the management system to UNI EN ISO 9001 and UNI CEI EN ISO 13485, preserve its effectiveness and improve it continuously;
  • measure and improve the quality of the products supplied;
  • verify the system and its processes through internal and external audits, performance indicators and continuous comparison with the market.

People, suppliers and development

  • develop the professional skills of employees and collaborators through training;
  • involve suppliers increasingly in the achievement of quality and keep their performance under control;
  • continuously seek new products and new solutions for an evolving market, developing collaborations in national and international research projects;
  • develop the sales network in Italy and abroad through distribution, resale and agency agreements, including electronic marketplaces, and through synergies with leading companies in the sector.

Trento, Italy, 17 September 2026

The Sole Director