[Q&A Seminar] Basic Seminar for Responsible Persons and Personnel in Charge of Medical Device Sales in Europe
S10623
★What are the steps to obtain the European Medical Device Directive (MDD) and how to estimate the necessary preparation time? ★What questions will the notified body not answer?
Lecturer Mr. Kenji Aoyama, President and Director of the Medical Device Regulatory QMS Research Institute, Inc. Target Audience: Business owners, marketing departments, development planning departments, regulatory management departments, etc., considering the sale of medical devices within the European region. Venue: Kawasaki City International Exchange Center, 2nd Floor, Room 5 [Kanagawa, Kawasaki City] 10 minutes on foot from Tokyu Mot sumiyoshi Station. Due to planned power outages, the venue may be changed to a location in the Tokyo metropolitan area. We will notify you one week before the event date. Thank you for your understanding. Date and Time: June 21, 2011 (Tuesday) 13:30-16:30 Capacity: 20 people. *Please apply early as there may be a rush of applications. Participation Fee: 49,350 yen (tax included, including text costs) for up to 2 people from one company. *New members who apply for the first time by June 7 will receive an early bird discount price of 44,100 yen. ◆ Early Bird Discount: Please select "1 slot for 2 people: Early Bird Discount" when registering. ◆ For additional applications from the same corporation, an additional 12,600 yen will be charged per person.
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basic information
Based on my knowledge and experience as a lead auditor for MDD/EN ISO 13485 and my track record as a consulting company in medical device regulations and QMS, I will provide essential information and explanations for companies that are investigating and planning to sell medical devices in Europe for the first time. 1. Explanation of the procedures for obtaining CE marking under the European Medical Device Directive MDD and estimation methods for the necessary preparation period. 2. Comprehensive explanation of the requirements of the European Medical Device Directive MDD. 3. Answers and explanations to questions that notified bodies (N/B) do not address, as well as providing information and explanations that N/Bs do not have. I plan to explain some examples from FAQs below. 4. We will allocate time to individually answer your company's specific questions and inquiries regarding your medical devices and QMS.
Price range
P2
Delivery Time
P2
Applications/Examples of results
1. Basic Steps to Obtain MDD Certification (CE Marking) 2. Key Points of MDD 93/42/EEC (Must be audited!) - What is a "single" 'Authorised Representative' (European representative)? - Is your product a medical device as defined by the MDD? An "Accessory"? - Which Rule from Rule 1 to Rule 18 does your product fall under, and is it Class I, IIa, IIb, or III? - Are sterilized devices or devices with measurement functions treated specially even if they are Class I devices that cannot involve a Notified Body? - What is the relationship between clinical evaluation, clinical trials, and clinical data? Is clinical evaluation mandatory? - What are the localization requirements? What should be noted in terms of compliance? What constitutes efficient compliance? - Is MDD internal auditing mandatory? What about the training and competency assessment of MDD internal auditors? - Is software also considered a medical device? - What content and items should be included in the technical file? How much should be in English? - What is a vigilance system? What are "post-market adverse event reports" and "FSCA"?
Company information
Our company has developed its business from "seminar planning" to various forms such as "lecturer dispatch," "publishing planning," "technical consultant dispatch," "trend research," "business matching," and "business development consulting," in order to support clients in a wide range of fields including chemistry, electronics, automotive, energy, medical devices, food, and building materials. By doing so, we have advanced our company and opened up new markets. AndTech promises to continue listening to our clients' voices, entering the business areas and markets they desire, and to remain a company that is loved by our clients, as we share their challenges, think together, and forge new paths.
