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CH-REP.com

Our main goals are to keep the additional costs for the foreign manufacturer as well as the Swiss importer and distributor as low as possible and at the same time to comply with all regulatory requirements.   

CH-REP.com is your direct point of contact - your service provider

CH-REP.com offers tailor-made, product specific services to foreign manufacturers as well as to importers and distributors in Switzerland:

CH-REP.com is a platform to experienced advisors/consultants with expertise in the medical technology industry. With our efficiency we are aiming for to keep additional efforts as low as possible while focusing and complying with all regulatory requirements.
 
CH-REP.com's  operators are your direct contractual partners. Availability and accessibility as well as substitution and continuity are ensured.


International Associates Limited

EU & UK Partner

International Associates (IA) is a leading provider of assemment, audit, verivication, certification and training services. From its headquarters in Glasgow, Scotland, its operates a network of international offices around the world, with regional offices in Ireland and Thailand, and a network of auditors around the world.

International Associates Limited is able to act as your agent or responsible person in Europe and the UK.

Best Care Consulting GmbH

Best Care Consulting (BCC) is a well established consulting company based on two pillars Pharma and Medical Device providing expertise in Product Development, QM, Audit, Training, Regulation and more. 

BCC offers advanced services to its international clientele  covering quality and regulatory expertise within medical device industry. BCC is a recognized partner who can support you in a variety of implementation issues in product development, usability, quality management, quality assurance, qualification & validation and operations. We are specialized in regulatory standards such as EN ISO 13485, EN ISO 14971, FDA QSR 21, CRF 820, DIN EN 62366 under consideration of MDR 2017/745 or IVDR 2017/746.

Together with our network, we take over projects adapted to the current needs of our customers, but also the daily business. We develop and implement solutions adapted to the needs of our customers.

Inspera GmbH

Inspera GmbH is an established consulting company that focuses on the medical device industry.

The focal points are Quality Management, Regulatory, Audit, Training.
Inspera GmbH offers its clientele expedient services in the areas of quality and regulation in the medical device industry.

A proven network enables us to access and cooperate with experts in the various disciplines of quality management and regulatory affairs.
Inspera's clients are located throughout the supply chain, from manufacturers of medical devices, service providers, legal manufacturers (from bandages to hips and from diagnostics to ophthalmology) and distributors, as well as hospitals.

The engagement with CH-REP.com is only a logical development of the offer in the sense of  the healthcare sector.
Medcore Suisse GmbH

Medcore Suisse GmbH is a established Consulting Company with focus on Regulatoy Affairs for the European Market (EU), the Asia Market (APAC) and eastern European Market (EEU). 

The Service includes in particular the elaboration of wheter a Product is to be classified as a Medical Device according to the regulation, its Risk classification and the assessment of the technical Documentation with regards to the requirements.

The Service covers all phases during the Product Life Cycle including Suppliers and Service Provider.

For Products of the Riskclassification I we support Manufacturers for tailor - made QM - Systems and technical Dokumentation adapted to the Indended Use and complexity of the Manufaturer.