Herniamesh S.r.l.
Herniamesh is an Italian company with a worldwide distribution network that manufactures and markets medical devices for inguinal and abdominal hernioplasty and the treatment of female urinary incontinence. The Herniamesh medical devices are the result of decades of research and development to supply top-quality products that are patented and functionally correct. Herniamesh guarantees the quality of its products by meticulously monitoring each step of the production process within a certified Quality Management system. The Herniamesh Training Centre organises courses for specialised personnel and sales forces. All the products are manufactured in compliance with the objectives of the company’s Quality System, in conformity with UNI CEI EN ISO 13485:2016 standards. They are CE-marked according to Annex II to the European Directive 93/42/EEC, except for clause 4. Most of the products have 510 (K) clearance, issued by the FDA, for sales in the USA.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Clinical Services
- Market Focus:
- Globally (various continents)
- Year Founded:
- 1995
About Us
From hernioplasty according to the technique of the company’s founder, Dr Ermanno Trabucco to the latest prostheses made using innovative technologies and materials.
The mission of Herniamesh is to provide surgeons with medical devices that meet the highest quality, safety and efficacy requirements. This goal is achieved through scientific collaboration with academics, universities and research centres.
Herniamesh products
The following pages contain technical information on Herniamesh® products. In compliance with the guidelines of the Ministry of Health of 17 February 2010 and subsequent of 28/03/2013 and 20/12/2017, this information is exclusively for specialised medical operators. The user is fully responsible for consulting the following pages.
Collaborations
Herniamesh® collaborates with the regional innovation hub and with hospitals.
Innovation
The Herniamesh R&D Centre
From hernioplasty using Trabucco’s “tension-free, sutureless” technique to the latest prostheses employing increasingly sophisticated technologies and materials in response to the demand for a better quality of life that patients expect from modern surgery.
The New Challenges
The future is born from changes in the present
The market is constantly evolving and the new challenges are to never lose focus on the world, to seize the right inspiration and to be able to responsibly offer innovative products. The market demands superior products. Expectations are on the rise and Herniamesh® is keeping up with the times, delivering efficiency and effectiveness, flexibility and precision. The attention and cooperation we devote to the scientific community is part of our value package.
Our objectives
Our challenge is to provide surgeons with products that can be used with maximum safety, certain of the experience that Herniamesh® has gained in the field.
Production Steps and Quality Controls
Inspections upon reception
The supplied products are inspected upon reception to make sure they comply with the requirements of the respective technical specifications.
Prosthesis manufacturing
Prostheses are made using specialised machinery.
Cleanroom
Herniamesh® has an ISO Class 7 controlled environment room.
In-line inspections
In-line quality controls are carried out at each step of the manufacturing process.
Packaging
The product is double-bagged in Tyvek or double-blister and completed with the sales packaging.
Certified Quality
Herniamesh® guarantees product quality by dedicating careful attention to each step of the production process within a certified Quality Management system compliant with ISO 13485:2016. All products are manufactured in compliance with the applicable industry standards and have CE marking following the applicable European medical device regulations. Herniamesh is committed to respecting organisational criteria in line with these requirements and pays attention to the market through continuous product improvement.