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We support you as CH-REP:

CH-REP = Swiss authorized representative

To comply with legal and normative regulations

To gain approval for medical devices, sold in the Swiss healthcare market

In the communication with the Swiss authorities

Our benefits

A brief guide to SMQS

Under observance of the applicable legal requirements, Swiss Medical Quality Services “SMQS” assists as CH-REP international manufacturers to gain the necessary approval to place their medical devices (MDR/IVDR) on the Swiss market.

As a Swiss authorised representative (CH-REP), we are acting on the manufacturer’s behalf, “SMQS” assumes responsibility for the formal and safety-related issues connected with placing the device on the market.

“SMQS” provides comprehensive services, which includes assistance with the device registration process, compliance and cooperation with the authorities in respect of all Field Safety Corrective Actions (FSCA).

Our customers are well-established Swiss and foreign companies with decades of experience in the Swiss medical and dental markets.

Our Team

(f.l.t.r.)

Bljetar Murati (Quality Manager)
Bljetar has over 10 years of experience in project management and quality management across the MedTech and food industries. In the highly regulated sector, Bljetar supports clients in strategic and regulatory matters, nationally and internationally.
E-mail: bljetar.murati@arnoldbottag.ch

Bernhard Ertel (Managing Director / Compliance)
Bernhard has more than 25 years of experience in the MedTech sector. As a product manager and managing director, he is responsible for sales, project management and close customer relationships. Due to his wide experience in the regulated sector, he supports clients in all matters of quality management and regulatory affairs.
E-mail: bernhard.ertel@arnoldbottag.ch

Deepa Manjaly (QM Project Manager)
Deepa has experience in MedTech and quality management. She handles and coordinates requests from national and international clients and supports them in regulatory matters.
E-mail: deepa.manjaly@arnoldbottag.ch

To all of our partners

Market access for medical devices in Switzerland

The Mutual Recognition Agreement (MRA) between the EU and Switzerland was not updated in May 2021. As a result, cooperation between the Swiss and EU authorities on medical devices has been suspended. Switzerland is treated as a third country in respect of medical devices (MDR products) and In-vitro-Diagnostic Devices (IVDR-products).

Consequently, the Swiss market surveillance authority Swissmedic no longer has access to EUDAMED and market surveillance data from the EU.

The Swiss Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) therefore sets out additional measures to ensure that Switzerland is able to monitor foreign medical devices within Switzerland. The requirements in this regard are equivalent to those of the EU Regulations on medical devices (MDR) and In-vitro-Diagnostic Device Regulation (IVDR). Amongst other things, the Ordinance stipulates the appointment of an Authorised Representative in Switzerland and an appropriate labelling of the imported devices.

Swiss Authorised Representative (CH-REP)

If the device manufacturer does not have its registered place of business in Switzerland, its devices may only be placed on the Swiss market once an Authorised Representative domiciled in Switzerland has been mandated in writing (Art. 51, para. 1 MedDO / Art. 44, para. 1 IvDO). This also applies to manufacturers with their registered place of business in the European Union.
Source: Market access (swissmedic.ch)

“SMQS” provides you with comprehensive Swiss Rep services including advising and assisting you in the implementation of the measures required for your medical device (e.g., labelling, adaptation of documentation).

The best service. From SMQS.

At “SMQS by Arnold Bott AG”, we specialize in smoothing the path of your products to market while complying with all applicable regulatory requirements.

We also support and advise all manufacturers, importers and distributors in the medical technology industry in the implementation of the applicable regulation in Switzerland.

We are able to do this thanks to our activities in the most diverse areas of medical technology and our proximity to the market. You thus have a strong partner with years of experience in the areas of “Regulatory Compliance, Regulatory Affairs, Quality Management and the national and international regulated environment” at your side!

Our benefits

Marktnähe Market proximity
  • Global co-operation with small companies and concerns

  • Close cooperation with the largest Swiss distributors and importers, thereby maintaining very good contacts with practising doctors and healthcare facilities
Marktzugang Market access
  • Fast and easy access for international manufacturers to the Swiss medical device market

  • Access to product experts, professionals and the distribution channels of our Swiss distribution partners, enabling rapid market launch of new products
Netzwerk Network
  • National and international business partnerships

  • Excellent contacts to opinion leaders and end-users


Schnelle Reaktionszeit Fast response time /
intervention time
  • On-the-spot communication

  • Direct access to the retail network of our Swiss distributors

  • Acting independently and agilely
Intensive Zusammenarbeit Close collaboration with business stakeholders at all process levels
  • Direct contact with economic players at all business levels

  • Influencing the marketing of retail products

  • Strategy and sales development with our Swiss distribution partners
Regulatorische Ziele Regulatory centre
  • Longstanding Swiss Medtech member

  • Experienced and qualified QM staff

  • Large international knowledge in regulatory field
Produktewissen Product knowledge
  • Over 50 years of experience in dealing with medical devices

  • Access to professionals / product managers / sales

  • Exchange with service professionals

  • Large product portfolio of our distribution partners

Our offer

Registration

SMQS assists manufacturers to gain necessary approval for medical devices on the Swiss market

Labeling

SMQS assesses whether medical device labelling and markings conform with requirements

Compliance

SMQS assumes responsibility for compliance with the statutory provisions governing the placing of medical devices on the market

Experience

SMQS is trusted by well-established Swiss and foreign companies in the medical and dental markets

Vigilance

SMQS fulfils reporting obligations and cooperates with the authorities in respect of all Field Safety Corrective Actions (FSCA)

Partner

SMQS is trustworthy, and all information and documentation from its partners are treated confidentially

Contact us!

    SMQS by Arnold Bott AG
    Industriestrasse 59
    8152 Glattbrugg
    Switzerland

    Opening hours (Mon. – Fri.)
    8.00 am – 12.00 pm
    13.30 pm – 17.00 pm

    Telephone/Fax
    Tel. +41 44 828 62 60
    Fax. +41 44 828 62 61

    E-Mail
    info@smqs.ch

    Swiss registration number
    CHRN-AR-20001948

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    • Home
    • About us
      • Arnold Bott
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      • Service
      • Our benefits
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      • ISO 13485 certificate
    • Contact
    • English
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