Professional Quality And Regulatory Services

Through our very strong QA&RA expertise, we help our customers to acquire regulatory approvals globally, as well as create and improve their Quality Management System.

To ensure the safety and effectiveness of medical devices, the company needs to create a Quality Management System and build company processes according to QMS to ensure the regulatory requirements are met through the product whole life cycle. From the early product specification phase to sales approvals, production processes, supplier control and even after-sales services, it is mandatory to know and follow the regulations related to each phase in order to get the regulatory approvals for medical product. To read more about this subject, please follow this link.

We partner with our customers and help them to proceed with all Quality and Regulatory actions. We offer our customers clear and concrete advices about Quality and Regulatory related issues; help them to achieve regulatory approvals globally; and together with our customer, we create and maintain certified QMS which is based on the company’s own operation at the very practical level.

“As our global footprint expands, it is very important for us to be aware of local laws and regulations. Innokas' experience in quality and regulatory matters will help us in taking all necessary aspects into consideration at an early stage."Mikko Savola
Mikko SavolaCEO, Monidor
"To be able to sell the monitor to any country VC150 has to have both medical device approval and radio device approval. Innokas acquired CE mark for European market, the 510(k)-clearance for the device for the US market as well as the required market area specific radio device approvals.”Juha Rantala
Juha RantalaProduct Manager, Innokas Medical Ltd.
“The cooperation with Innokas helps us to ensure that all the quality and regulatory requirements that the authorities have appointed to this sector, are taken into account in Optomed’s internal processes. We’ve been very satisfied with the cooperation with Innokas QA/RA team.”Jyri Leskelä
Jyri LeskeläQuality Manager, Optomed
"We have been very satisfied with the cooperation with Innokas’ experienced QA/RA team. The QA/RA consulting Innokas team offered us were based on our own operation at the very practical level which we found very valuable."Manne Hannula
Manne HannulaManaging Director, Otometri

how to ensure the quality compliance of your medical product

Quality Service Offering

Quality System

Quality System

In co-operation with our customer, we build and help maintaining medical device quality management system to comply with relevant regulations (e.g. ISO 13485:2016, ISO 9001:2015, US FDA QSR and CMDCAS).

Service can include quality manual and other QMS documentation in accordance with the ISO 13485, ISO 9001, US FDA QSR and CMDCAS standards written in English or Finnish.

Continuous support of your company QMS including internal audits, CAPA, management reviews and conveying up-to-date information about regulatory requirements and other tasks.

Regulatory Affairs

Regulatory Affairs

Supporting your engineering project to achieve medical device & IVD regulatory approvals with our experience (EC certificate, FDA 510(k) applications, documentation around other market approvals).

Helping you to understand MD Classification rules / initial medical device classification and to recognize the applicable standards for different approval processes.