SHARING OUR VISION
To ensure that people understand the regulations and quality systems role in creating a successful business.
To fully understand the effects a new regulation has on a business it is important to be trained and hear what others have done. In our trainings we limit the class to max 20 people to ensure that you have the chance to hear and be heard and talk about you particular problems. In order to give our customers a quick planning.
PRRC
Do you need to now what Person Responsible for Regulatory Compliance (PRRC) requirements means to you!
Location: Virtual
When: February 16, 2021
March 16, 2021
April 20, 2021
May 18, 2021
Language: English
Costs: € 400 excl VAT if applicable (paid in advance)
Introduction:
This is a 4 hours course. The MDR and IVDR require that manufacturers and Authorized representatives have a person responsible for regulatory compliance PRRC. Article 15 of the MDR/IVDR determines the expertise and responsibilities. MDCG 2019-07 clarifies this further but leaving many thing unanswered.
Learning objectives:
• What is the work
• Understand the background of MDR/IVDR to understand PRRC requirements and where they are coming from.
• Liability of the PRRC.
• What are the roles and responsibilities of PRRC.
• Qualifications of PRRC.
• PRRC and your QMS
• Checks to fulfill for Post-market surveillance obligations.
• Reporting obligations for recording and reporting of incidents and field safety corrective actions.
Who should attend:
• Persons responsible for regulatory compliance
• Person that are considering to be PRRC
• Authorized representatives
• Professionals preparing for the MDR/IVDR
• Legal departments
Send an email to info@lowendahl.eu to with date and participant name.
March 16, 2021
April 20, 2021
May 18, 2021
Language: English
Costs: € 400 excl VAT if applicable (paid in advance)
Introduction:
This is a 4 hours course. The MDR and IVDR require that manufacturers and Authorized representatives have a person responsible for regulatory compliance PRRC. Article 15 of the MDR/IVDR determines the expertise and responsibilities. MDCG 2019-07 clarifies this further but leaving many thing unanswered.
Learning objectives:
• What is the work
• Understand the background of MDR/IVDR to understand PRRC requirements and where they are coming from.
• Liability of the PRRC.
• What are the roles and responsibilities of PRRC.
• Qualifications of PRRC.
• PRRC and your QMS
• Checks to fulfill for Post-market surveillance obligations.
• Reporting obligations for recording and reporting of incidents and field safety corrective actions.
Who should attend:
• Persons responsible for regulatory compliance
• Person that are considering to be PRRC
• Authorized representatives
• Professionals preparing for the MDR/IVDR
• Legal departments
Send an email to info@lowendahl.eu to with date and participant name.
Technical dokumentation
Do you need to know what the requirements are on the technical documentation required by IVDR and MDR this is the training for you!
Location: Virtual
When: February 16, 2021
March 16, 2021
April 20, 2021
May 18, 2021
Language: English
Costs: € 500 excl VAT if applicable (paid in advance)
Introduction:
This is a 4 hours course. MDR and IVDR introduces a new way of presenting technical documentation, with a much broader view than todays IVDD and MDD. What can be reused what needs to be created. This particular requirement are a big change for IVD´s.
Topic overview
• Annex II technical documentation
• Annex III technical documentation
• Life Cycle
• PSUR & SSCP
• Case studies
• Questions & Answers
• Reporting obligations for recording and reporting of incidents and field safety corrective actions.
• What shall AR check
Who should attend:
• RA and QA people
• Authorized representatives
• R&D people
Send an email to info@lowendahl.eu to with date and participant name.
March 16, 2021
April 20, 2021
May 18, 2021
Language: English
Costs: € 500 excl VAT if applicable (paid in advance)
Introduction:
This is a 4 hours course. MDR and IVDR introduces a new way of presenting technical documentation, with a much broader view than todays IVDD and MDD. What can be reused what needs to be created. This particular requirement are a big change for IVD´s.
Topic overview
• Annex II technical documentation
• Annex III technical documentation
• Life Cycle
• PSUR & SSCP
• Case studies
• Questions & Answers
• Reporting obligations for recording and reporting of incidents and field safety corrective actions.
• What shall AR check
Who should attend:
• RA and QA people
• Authorized representatives
• R&D people
Send an email to info@lowendahl.eu to with date and participant name.
General MDR
Do you need to understand the new regulation, MDR in EU for medical devices this course is for you!
Location: Virtual
When: February 18, 2021
May 19, 2021
Language: English
Costs: € 500 excl VAT if applicable (paid in advance)
Introduction:
This is a 5 hours course. We will go through all the requirements MDR have and make a deep dive in the most important parts of the regulations
Learning objectives:
• What are the biggest changes
• What players are effected
• Rules and what they mean
• What to do now!
• Timelines
Who should attend:
• QA,RA, R&D, Managers
Send an email to info@lowendahl.eu to with date and participant name.
May 19, 2021
Language: English
Costs: € 500 excl VAT if applicable (paid in advance)
Introduction:
This is a 5 hours course. We will go through all the requirements MDR have and make a deep dive in the most important parts of the regulations
Learning objectives:
• What are the biggest changes
• What players are effected
• Rules and what they mean
• What to do now!
• Timelines
Who should attend:
• QA,RA, R&D, Managers
Send an email to info@lowendahl.eu to with date and participant name.
General IVDR
Do you need to understand the new regulation, MDR in EU for medical devices this course is for you!
Location: Virtual
When: February 18, 2021
May 19, 2021
Language: English
Costs: € 500 excl VAT if applicable (paid in advance)
Introduction:
This is a 5 hours course. We will go through all the requirements MDR have and make a deep dive in the most important parts of the regulations
Learning objectives:
• What are the biggest changes
• What players are effected
• Rules and what they mean
• What to do now!
• Timelines
Who should attend:
• QA,RA, R&D, Managers
Send an email to info@lowendahl.eu to with date and participant name.
May 19, 2021
Language: English
Costs: € 500 excl VAT if applicable (paid in advance)
Introduction:
This is a 5 hours course. We will go through all the requirements MDR have and make a deep dive in the most important parts of the regulations
Learning objectives:
• What are the biggest changes
• What players are effected
• Rules and what they mean
• What to do now!
• Timelines
Who should attend:
• QA,RA, R&D, Managers
Send an email to info@lowendahl.eu to with date and participant name.
FDA QSR requiremnts
Understand the QSR requirements and what they means to you in practice.
Location: Virtual
When: June 9, 2021
September 7, 2021
Language: English
Costs: € 500 excl VAT if applicable (paid in advance)
Introduction:
This is a 4 hours course. We will go through all the requirements in QSR and make a deep dive in some parts of the regulations. We will also go through to complete process from registering the company and product
Learning objectives:
• Knowing the QSR
• Practical issues
• What are the differences between MDR/IVDR and QSR
• The complete process getting to the market
Who should attend:
• QA,RA, R&D, Managers
Send an email to info@lowendahl.eu to with date and participant name.
September 7, 2021
Language: English
Costs: € 500 excl VAT if applicable (paid in advance)
Introduction:
This is a 4 hours course. We will go through all the requirements in QSR and make a deep dive in some parts of the regulations. We will also go through to complete process from registering the company and product
Learning objectives:
• Knowing the QSR
• Practical issues
• What are the differences between MDR/IVDR and QSR
• The complete process getting to the market
Who should attend:
• QA,RA, R&D, Managers
Send an email to info@lowendahl.eu to with date and participant name.
Economic operator
We go through what IVDR and MDR means for Distributors, Importers and Authorized representatives.
Location: Virtual
When: March 10, 2021
April 14, 2021
May 12, 2021
Language: English
Costs: € 300 excl VAT if applicable (paid in advance)
Introduction:
This is a 3 hours course. We will go through all the requirements MDR and IVDR will pose for distributors, Importers and Authorized represenatives you as di have and make a deep dive in the most important parts of the regulations
Learning objectives:
• What are the biggest changes
• What players are effected
• Rules and what they mean
• What to do now!
• Timelines
Who should attend:
• QA,RA, R&D, Managers
Send an email to info@lowendahl.eu to with date and participant name.
April 14, 2021
May 12, 2021
Language: English
Costs: € 300 excl VAT if applicable (paid in advance)
Introduction:
This is a 3 hours course. We will go through all the requirements MDR and IVDR will pose for distributors, Importers and Authorized represenatives you as di have and make a deep dive in the most important parts of the regulations
Learning objectives:
• What are the biggest changes
• What players are effected
• Rules and what they mean
• What to do now!
• Timelines
Who should attend:
• QA,RA, R&D, Managers
Send an email to info@lowendahl.eu to with date and participant name.