🇨🇿 How to Develop a Bulletproof Compliance Strategy?

The event is held in Czech language only!

The seminar program is divided into three logical sections that will provide you with specific guidance for each phase of your project.

We’ll start by preparing to meet all legislative requirements, where we’ll clarify manufacturers’ basic obligations, familiarize ourselves with key documents, and map out the individual milestones along the journey—from the initial design to market launch. We’ll explain what an effective regulatory strategy is and how it works.

In the second part, we’ll focus on a foolproof strategy for conformity assessment. We’ll demonstrate just how critical the definition of the intended purpose and the classification of the device are. We’ll also cover how to effectively engage with a notified body and how to set a realistic timeline. Last but not least, we’ll examine the most common mistakes and pitfalls in this part of the process.

Finally, we’ll provide an overview of how to prepare for a successful market entry, covering the necessary registration requirements, setting up systems for collecting feedback (PMS and PMCF), and managing vigilance in day-to-day practice.

Who the webinar is for:

• Anyone considering starting the development or manufacture of a medical device

• Start-ups

• Regulatory specialists at medical device and IVD manufacturers

• Persons responsible for regulatory compliance (Article 15 of the MDR)

• Quality directors, systems engineers, and business owners seeking to optimize their organizational structure

• Employees of medical device manufacturers responsible for development

• Specialists involved in the creation of technical documentation

• Anyone working in the medical device industry who wishes to broaden their knowledge of this topic

• Investors considering entering the medical device manufacturing sector

• Anyone who doesn’t want to constantly be “playing catch-up” in the regulatory arena

Lecturers:

• Ing. Aleš Martinovský

• Ing. Jakub Musil

Content:

INTRODUCTION TO MEDICAL DEVICE REGULATION

• Definitions of key terms, basic obligations of manufacturers

• Information sources and key regulatory documents

• The life cycle of medical devices (from design to disposal)

• Overview of the main conformity assessment processes and their interrelationships

• Drafting a regulatory strategy

A BULLETPROOF CONFORMITY ASSESSMENT STRATEGY

• Defining the intended purpose and classification as key initial decisions

• Time and financial plan for conformity assessment/certification

• The certification process, finding a Notified Body

• Conformity Assessment as Part of the Regulatory Strategy – Major Pitfalls and Common Mistakes

HOW TO PREPARE FOR A DEVICE’S MARKET ENTRY

• Overview of Notification and Registration Requirements

• PMS and PMCF (Feedback Collection)

• Post-Market Processes as Part of the Regulatory Strategye

Additional information:

• During the webinar, participants will have the opportunity to ask questions

• Each participant will receive a certificate of participation

• A PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT

• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar hosted by:

• Porta Medica s.r.o.

  ID: 03301931, VAT: CZ03301931

  Registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město