This page is aimed at management, particularly executives at medical device and IVD manufacturers, notified bodies, authorities, and service providers responsible for regulatory and clinical affairs, quality management, and development.

Important tasks of management

The management tasks of these executives include, for example:

Information management

Collecting information from outside, keeping track of it, and taking the necessary measures. This includes information about

  • regulatory changes,
  • market trends (technologies, competitors, customers) and
  • the company’s own devices (post-market surveillance)

Quality management and strategy

Better positioning of your departments:

  • Initiating strategic projects (e.g., digitalization, outsourcing, restructuring)
  • Defining regulatory strategies
  • Contributing to the improvement of the QM system (e.g., during management reviews)

Resource management

Create the necessary preconditions:

  • Selecting service providers and negotiating contracts
  • Creating, securing, and monitoring budgets for the departments
  • Ensuring the size and competence of teams of experts

Support for management

Many managers rely on the support of the Johner Institute. It supports management with or takes over tasks from them.

a) Outsourcing

Managers outsource regulatory activities and processes to the Johner Institute:

Manufacturers also outsource roles such as QM representative, EU representative, or PRRC.

b) Consulting

Managers rely on the advice and opinion of the Johner Institute:

The Johner Institute supports medium-sized and large manufacturers in the digital transformation of regulatory processes and quality management.

If you are an executive, feel free to contact us now. You will receive fast, discreet, and competent support.


MDR transition periods

In Article 120, the MDR establishes its transitional provisions, including the transition periods. However, the descriptions of these transitional provisions and transition periods are worded in a very complex manner. As a result, manufacturers are at risk of misunderstanding them and therefore not complying with regulatory requirements or incurring unnecessary costs. A flow chart in chapter 2 of this article…

Details

7 tips for the successful digital transformation of medical device manufacturers

Companies need to master the digital transformation quickly and successfully. This also applies to medical device manufacturers because, after all, their future depends on it. Many companies make severe mistakes during this transformation (see section 4). This article provides managers with a quick overview of the possibilities of digital transformation and gives seven tips to make it…

Details

Remediation: When things hit the fan

“Remediation” is often synonymous with maximum stress: Notified bodies or authorities such as the FDA have discovered significant deviations that must be remedied with the highest priority and without regard to the workload of employees or budgets. This article will help you to complete such “remediation projects” in such a way that 1. Remediation: First…

Details

Transitional provisions of the IVDR

In December 2021, the EU extended the transitional periods of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) (Regulation 2022/112). In March 2023, the European Commission decided to abolish the “sell-off period” for IVDs that comply with Directive 98/79/EC (IVDD) (Regulation 2023/607). In January 2024, the European Commission published a proposal to amend the IVDR, which further extends…

Details