Validation in medical technology: it can not be done without

Are you and your company prepared for the new ISO 13485: 2016? The transition period for the old ISO 31 ends on March 2019, 13485.

This affects all companies that produce, store, install and provide medical device products within the scope of this standard. In addition, the ISO 13485: 2016 is also mandatory for service providers and suppliers.

One of the most important innovations: These companies then have to validate computer-aided systems that they use for their own process control. This includes the ERP software. Validated is not the software itself, but the way the software is used.

We accompany you in the validation of your company and your processes according to ISO 13485: 2016 and other national and international standards.

%% MCEPASTEBIN

Important standards and regulations to which we advise you:

  • ISO 13485: 2016
  • ISO TR 800002 2
  • MDR Television
  • GAMP 5
  • MDSAP

The new ISO 13485: 2016 entered into force on April 1, 2019.

Our consulting packages for successful validation

In complying with regulatory standards, we not only assist you with the provision of our validated ERP software for medical technology, but also with the validation of your business processes depicted in the software.

Benefit from our consulting packages and services. We help you validate your software-based business processes, helping you meet national and international compliance requirements. Upon request, we will accompany you until successful validation of your ERP system.

Validation kick-off

In a one-day workshop, together with you and our partner, we determine the status of your system and define the steps needed to bring your ISO validation to a successful conclusion.

The result is your complete, individualized validation roadmap.

  • Requirements for software validation are presented
  • Necessary steps for the individual validation of your company - not only according to ISO 13485: 2016 - are elaborated and defined
  • Required and existing documentation will be checked

Basic documentation

Optionally we offer you further services around the validation process:

Using pre-prepared templates, we will work with you to prepare the basic documentation for your validation.

Accompanied until successful validation

As part of an extended support we support you individually: from the tasks defined in the kick-off to the successful completion of your validation. We will gladly prepare an offer after the "Validation Kick-Off", in which the content and scope are defined.

Everything you want to know. Everything you need.

We support you in fulfilling the regulatory requirements in Germany and abroad. With our customized consulting package and our ERP industry solution for medical technology.

datenblatt_validierung.jpg

Comprehensive know-how for processes and software

In the validation we cooperate with competent partners in the fields of IT quality management and validation, which specialize in customers from the pharmaceutical and chemical industries as well as medical technology. Together with our network, we offer you comprehensive expertise in the validation of computer-aided systems - both in the national and international environment. 

Successful ISO 13485: 2016 validation for your business. Do not waste time and make an appointment now for our consulting package "Validation Kick Off".

KUMAVISION ERP: Industry-proven, validatable and future-proof

ERP manufacturers such as KUMAVISION indirectly contribute to successful validation according to ISO 13485: 2016. Because you have to provide the functions and workflows that are required for the correct use of the ERP software at the customer and thus also for the validation.

KUMAVISION ERP for medical devices is validatable and helps you to meet the requirements of ISO 13485: 2016, MDR and FDA.

KUMAVISION ERP is based on many years of experience in the regulated environment and has numerous industry-specific functions for medical technology:

  • Compliance support (ISO, MDR, GMP or FDA)
  • Graded user authorization concept
  • Four eyes principle with approval workflows
  • Audit Trail (complete tracking of changes)
  • Quality Management (QM)
  • Risk and Complaint Management (FMEA)
  • Integrated, audit-proof document management system (DMS)
  • Supplier Evaluation
  • Tracing of serial and batch numbers (traceability)
  • Unique Device Identification (records, label printing, upload in GUDID)
  • Electronic device file (Medical Device File)
  • Validation of KUMAVISION software and development processes

Specialist article: When ERP meets ISO 13485: 2016

Logo Spectaris

Read in our guest article for the Spectaris Yearbook how integrated ERP software supports medical device manufacturers and distributors in validating to ISO 13485: 2016.

Validation FAQs

We have collected answers to the most frequently asked questions and the most important facts about the subject of validation in medical technology and compiled them clearly.

Change Management / Change Control / Change Management

A formal process by which qualified representatives of the disciplines involved examine proposed or implemented changes to a computer system. The main goal is to document the changes and ensure that the system is kept in a controlled state.

The FAQs were provided with the kind support of VQC Consulting.

deenit