Healthcare innovation is in the heart of our co-founders’ DNA and our vision is to bridge the gap between idea and implementation by offering an Plug-and-Play quality management system (QMS) and acting as legal manufacturer.

The Effectum Medical team unites hands-on MedTech business and management experience with in-depth knowledge of regulatory affairs and quality management for medical devices, medical software and in-vitro diagnostic products. In addition, we provide access to a unique network of experts along the entire value chain.

Not only Startups, but also R&D, Regulatory Affairs and Quality Management teams of established MedTech Companies can count on us as an external service provider.

Through Effectum CH-REP, a company of Effectum Medical, we give companies domiciled outside of Switzerland access to the Swiss market by acting as their Swiss Authorized representative.

Our Plug-and-play QMS

• is compliant with ISO 13485, MDD/MDR, IVDD/ IVDR and FDA standards

• covers more than 40 norms

• has a modular concept with 30 Standard Operating Procedures (SOP’s) and 150 templates

• is enriched with individual service packages

• has withstood 9 Notified Body audits in the last five years

• A QMS applied daily for medical devices, medical software and IVD products

• A QMS continuously enhanced to ensure optimal workflows

• A QMS regularly audited by notified bodies and customers

• Through our QMS 8 products have been successfully certified and more than 10 are in the pipeline

• We actively apply the same framework for our legal manufacturer services

➡️ Plug & Play QMS Service Overview⬅️

Outsourced Legal Manufacturer

• are responsible for Post Market Surveillance, Vigilance & Complaint Handling

• take care of supplier validation and audits

• handle the operations part from production until delivery to warehouse

• keep all documentation needed to maintain product certification up to date

• Focus on innovation, product development and technical documentation

• Shorten time to market by splitting roles and responsibilities

• Avoid wasting resources on non-core activities, e.g. preparation and realization of audits

• Overcome the current shortage of Notified Bodies

When you Choose Us
What Makes Us Different?

We maintain a quality management system according to ISO standards for medical devices.

We share the risk by acting as legal manufacturer for your product.

We support you in maintaining your product registration (i.e. process validations, post market surveillance, etc.).

We offer organizational structure & back office services, enabling you to focus on your core business.

We offer a wide range of services and infrastructure
you choose what you need

Team
.

Interdisciplinary core-team with competence and experience in

ISO Certification
Product development
Product registration
Marketing
Business development

Infrastructure
.

Encompassing infrastructure & services

Quality Management System (ISO)
Legal Manufacturer
Central back office services

Network
.

Extensive network of partners and experts

Suppliers & manufacturers
Surgeons of different specialties
Scientific & technical experts
Financing partners

Project
Management

Profound project management skills in

Project coaching
Set-up & planning of projects
Project management
Processes
Systems (profit center, QMS, PLM, contracts, etc.)

Our Core Values

Innovative

The DNA of Effectum Medical is an innovative business model. It is therefore only natural that we are always on the lookout for new solutions for our partners and customers to jointly pursue future-oriented paths.

Efficient

Lean structures and a clear understanding of our customers’ needs and the crucial elements in the product approval process, allow us to work in a solution-focused and target driven manner.

Strong in
implementation

We do not see ourselves as theorists. We want to successfully bring our customers' ideas to market. Conceptual thinking combined with pragmatism makes us a strong partner who knows what really matters.

Agile

We understand the requirements of an agile product development and live this approach for our customers. A clear customer focus and high-quality service are very important to us.

Competent

We are reliable partners in the fields of quality management, regulatory affairs, and project management, who possess not only specialized knowledge but also a wealth of operational experience along the entire value chain - from idea to global roll-out.

Respectful

Respect and recognition are an important basis for a successful collaboration. A partnership of equals is what we strive for - with our customers, suppliers and as a team.

08. November 2023

New opportunity – Quality Manager Medical Devices 60-80%

We are currently looking for a

Quality Manager Medical Devices (60-80%)

to join our team.

In this position

Are one of the key players for the optimization of our modular certified eQMS, covering active devices, software, non-active devices and in-vitro diagnostics and various geographies
Are the subject matter expert (SME) for Change Control, Complaints, Non-Conformities and CAPAs and you will be in charge of the daily business management for these processes and all related activities. As SME you will ensure the continuous improvement of the processes and will participate in meetings with customers regarding changes and other pending activities.
Are involved in final product release and product quality management.
You are a key player in external (notified body, authority, customer) audit preparation and participate in external audits.
You are involved in performing internal and supplier audits in accordance with the annual audit program. You are involved in supplier quality related tasks such as supplier selection, review and monitoring.
You are a key player in the setting up and training of new eQMS customers and assist them during their path to certification.
You assist in other quality management activities such as Post-Market Surveillance reporting, Computer System Validation, employee training and are an eQMS administrator.

Effectum’s Plug & Play (e)QMS Bootcamp

Are you a medical device start-up and the topic of quality management system (QMS) gives you more stress than pleasure?

Do you associate with QMS a lot of work that is not really part of your core competence but a necessary evil of your venture?

Then this workshop is just right for you. In our modular and hybrid bootcamp, you will acquire an ISO 13485 QMS, which continuously maintained and can be adapted to your needs.

Curious? Then contact us for more information and save your early bird ticket before August, 15th.

2023-Plug-Play-Bootcamp-Effectum-Medical-2.pdf (0 downloads)

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Our Plug-and-play QMS

Outsourced Legal Manufacturer

When you Choose Us
What Makes Us Different?