MedqTech konsult

Regulatory

We have broad regulatory experience within the Medical Device Industry. We can support your team and project in the CE-marking process with Gap analysis and/or technical documentation. We can help you classify your product and identify applicable standards.

Example of our support:

  • Applications/registrations: EU/US
  • Gap analysis (product standard)
  • Classification of products (MDD, IVDD, MDR, IVDR)
  • Set up Regulatory strategy
  • Communication with Notified Body
  • Act as your Regulatory Responsible Person (MDR/IVDR)
  • Act as project managers in development projects

… and other regulatory support

Quality

We have extensive experience in the quality field for Medical Device industry. We can support in writing specific processes or support you in implementing a full Quality Management System in compliance with ISO 13485:2016.

Other examples of support:

  • Certification ISO 13485, ISO 9001
  • Facilitation of Risk Management, ISO 14971
  • Internal audits, supplier audits
  • Lead auditors
  • Non-conformities and root cause analysis, CAPA
  • Implementations of processes, for example Post Market Surveillance, CAPA, Vigilance & recall processes
  • Act as resources within the quality department
  • Change management in organizations
  • Work with improvement and process management
  • Creating and maintaining quality system documents

…. and other quality affairs support

Education

We provide customized training within the regulatory and quality field in the Medical Device Industry.

Tell us about you needs and let’s discuss how we can support you.

Support

We support our customers in all types of questions independent of the size of the assignment.

From solving one specific questions to long periods of support in regulations and quality issues that is currently happening in your day to day business.

We have long experience in MDD, IVDD, ISO 13485, ISO 9001, ISO 14971, IEC 62366, IEC 62304, QSR (FDA 21 CFR Part 820, Part 11) and other regulations and standards in medical device industry.

Partners

Together with our partners, we can offer our customers professional support in a very broad area within Medical Device regulations.

As an experienced team, our aim is to support you as a customer in a timely and cost effective way.

Our main partners

NIMIO AB

Vinga Medtech Q Consulting AB

QP Konsult AB