Client

Perivision

Startup company

Based in Lausanne

Striving to make eye testing & care accessible to everyone – everywhere

The Challenge

Perivision lacked an ISO 13485 QMS and internal regulatory expertise when developing VisionOne. Achieving MDR compliance quickly was critical for market access and to avoid missing out on sales opportunities.

Due to limited in-house resources, Perivision needed a strategic partner to guide them through the complex MDR certification process and provide ongoing compliance support.

Solution

Perivision appointed Effectum Medical (EM) as their legal manufacturer, leveraging EM’s existing MDR-compliant QMS, regulatory expertise, and established Notified Body relationship. Effectum Medical’s expertise as legal manufacturer allowed Perivision to focus on innovation and accelerate their product launch.

Results

12-Month Accelerated Certification: VisionOne achieved MDR/CE certification 12 months ahead of schedule thanks to EM’s Fast Track Certification Process. Reduced Risk & Cost: Leveraging EM’s QMS avoided significant investment & internal resource allocation.

Smooth Market Access: 

VisionOne is now successfully marketed in six European markets, revolutionizing glaucoma diagnosis and monitoring.

Client

Global supplier for Pharma, pioneering in the development and manufacturing of auto-injectors, 4’000 employees and 110 million US $ turnover

Swiss/Taiwanese

Development of a sterile pediatric device for drug administration (MDR class Is)

The Challenge

The client acquired an engineering company with an ongoing development project for the device. Neither company was prepared to act as legal manufacturer. Time to market was crucial due to patent expiration and hard market registration deadlines for the combination product (micro-dosing device and drug).

Solution

Effectum Medical (EM) accompanied the client throughout the development process, including verification and validation, supported with the selection and qualification of suppliers.The establishment of the technical documentation in the QMS of EM ensured compliance and on-time certification.

Results

CE certification for the device was obtained within 7 months after submission, meeting the hard deadline. Since certification in early 2023, four batches have been manufactured, and the device is sold in Europe and the UK.

Motivation/Scope

Development of trial components which are compatible with an

existing third-party arthroplasty system.​

​

Challenge

 The customer had no internal engineering and no quality management

system. It wasn’t economical to implement all of it for this project.​

​

Solution 

Outsourcing of engineering and quality management to Effectum Medical.

Effectum Medical acts as legal manufacturer.​

EM-Team

Design Engineering, Regulatory and Quality Management, Independent

Reviewer​

Achievement

Product development, certification and production was realised within

6 months and the customer could apply the new surgical technique, using the new

instruments, in the OR.​

Client

Biospectal SA

Startup company

Based in Lausanne

Developed OptiBP, an app which can optically measure blood pressure using a smartphone’s camera

The Challenge

For Biospectal, time-to-market was crucial.

However, they lacked the in-house expertise to establish a Quality Management System (QMS) and obtain ISO 13485 certification for the company, as well as certification under the Medical Device Regulation (MDR) to launch their product in the EU, Switzerland, and the UK.

Furthermore, the MDR’s activation had overwhelmed Notified Bodies, preventing them from serving Biospectal promptly.

Solution

Through EM’s (Effectum Medical’s) legal manufacturing service, Biospectal gained immediate access to Effectum Medical’s certified Quality Management System (QMS) and was able to establish their technical documentation under the expert guidance of EM’s specialists.

This allowed Biospectal to focus on their core expertise: product development.

Results

The technical documentation was established within nine months, and CE certification for OptiBP was obtained within 14 months after submission.

OptiBP went live in January 2024, with several hundred licenses sold in this short time.

High growth is expected in the coming months.