confinis

Medical Equipment Manufacturing • Düdingen, Fribourg, Switzerland • 21-50 Employees

Company overview

Headquarters	Hauptstrasse 16, Düdingen, Switzerland/USA/UK 3186, CH
Phone number	+441223421410
Website	confinis.com
NAICS	3391
SIC	874
Keywords	Quality Management, Medical Devices, Regulatory Affairs, Iso 13485, Iso 14971, Combination Products, Drug Delivery, Iec 62304, 21 Cfr Part 11, Iec 60601-1, 21 Cfr Part 820, Mdsap, Design Control, Ivdd, 21 Cfr Part 4, Iec 62366-1, Mdd 93/42/Eec, Sor/98-282, Ivdr 2017/746, Mdr 2017/745, Ch-Rep
Founded	2005
Employees	21-50
Socials

Key Contacts at confinis

Andrea Biasiucci

Chief Executive Officer

Beat U. Steffen

Founder & Principal Consultant

Claire Pittet

Executive Assistant To Chief Executive Officer

confinis Email Formats

confinis uses 2 email formats. The most common is {first name}.{last name} (e.g., john.doe@confinis.com), used 60% of the time.

Format	Example	Percentage
{first name}.{last name}	john.doe@confinis.com	60%
{first initial}.{last name}	j.doe@confinis.com	40%

About confinis

confinis is a regulatory consultancy specializing in providing advice and services to the medical device, combination product and IVDD manufacturers. confinis' core competences are in business practices - quality management and regulatory affairs services (21 CFR Part 820, 21 CFR Part 4, MDR 2017/745, IVDR 2017/746, CMDR, ISO 13485, MDSAP), design control, clinical evaluation, software development life-cycles (e.g. IEC 62304), product risk management (ISO 14971), human factors (IEC 62366-1), electrical safety (IEC 60601-x), validation (computer system validation, process validation, GAMP 5, 21 CFR Part 11 etc.), remediation activities, auditing, training and project management, with particular expertise in new product development from idea through registration to commercialization and post-market activities. confinis was instrumental in obtaining market authorization for way more than 2'000 medical devices and 200 combination products. We also provide the service as a Swiss Authorized Representative (CH REP) and a UK Responsible Person (UK RP).

confinis revenue & valuation

Annual revenue	$2,053,320
Revenue per employee	$86,000
Estimated valuation?This valuation is estimated based on industry average for the Medical Equipment Manufacturing industry and current estimated revenues	$6,600,000
Total funding	No funding

Employees by Management Level

Total employees: 21-50

Seniority

Employees

Senior

C-Suite

Entry

Employees by Department

confinis has 16 employees across 4 departments.

Departments

Number of employees

Funding Data

confinis has never raised funding before.

confinis Tech Stack

Discover the technologies and tools that power confinis's digital infrastructure, from frameworks to analytics platforms.

reCAPTCHA

Security

Gravity Forms

Form builders

iubenda

Cookie compliance

Tailwind CSS

UI frameworks

Animate.css

UI frameworks

Microsoft 365

jQuery Migrate

JavaScript libraries

Apache HTTP Server

Web servers

Alpine.js

JavaScript frameworks

Twitter Emoji

Font scripts

jQuery

JavaScript libraries

PHP

Programming languages

Frequently asked questions

confinis is located in Düdingen, Fribourg, CH.

You can reach confinis at +441223421410.

confinis was founded in 2005, making it 21 years old. The company has established itself as a significant player in its industry over this time.

confinis has approximately 21-50 employees. The company continues to grow its workforce to support its business operations and expansion.