GxP and Medical Device Compliance Services
 
 

Consultys, the market reference in pharmaceutical and medtech consulting

Consultys, a local and international partner, with more than 360 employees working on major projects for the world’s leading pharmaceutical, biotech and medical device companies.

Driven by a company philosophy based on human values, proximity and professional excellence, we enable highly regulated companies to accelerate the compliance process and get on the market faster while reducing costs and improving efficiency on a 1:1 basis.

Our goal is to help life science clients leverage their existing strengths and develop new capabilities by combining our experience and innovative thinking across in the regulated environment.

 
Medical Device - Technical Files

Medical Device Technical File

A CE Marking Technical File or Design Dossier (Class III) is a comprehensive description of your device intended to demonstrate compliance with European requirements.  Learn more

 
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GMP Supplier Audits

Consultys provides compliance and quality assurance services that are client tailored and fully aligned with FDA and EMA requirements to the pharmaceutical industry Learn more

 
QMS ISO:13485 Services

QMS ISO 13485

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services. Learn more

 
Qualification and Validation Services

Qualification and Validation

Our experienced commissioning and qualification team has the technical skills and experience to make our clients' projects successful. Learn more

 
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Latest Company News

Announcement (20.05.2019): Swiss Merger to become one of the largest LifeScience Consultancy Firm in Switzerland. Press Release

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Data Integrity (DI) 

Pharmaceutical Data Integrity (DI) is more important than ever. With radical pharmaceutical industry changes in the air, the importance of DI and the steps must take are clear. Learn more

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New EU MDR 2017

The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years.  Learn more

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We are hiring

Consultys offers a wide range of opportunities for your professional development. Browse our pages to learn more about your options within our team.  Learn more


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