SBS - The best value in QMS software

Guidance on Preparation for EASA Certification wanted

  • Thread starter Kasturi.P.Shetty
  • Start date
K

Kasturi.P.Shetty

#1
Hi Everyone!

Presently our company is certified for AS9100 Rev c, Now our managemnt is decidied to go for EASA Certification, What are the things we need to prepare like manual,Procedures, Templates we are totaly new to this please guide us.


Regards
Kasturi
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hi Everyone!

Presently our company is certified for AS9100 Rev c, Now our management is decided to go for EASA Certification, What are the things we need to prepare like manual,Procedures, Templates we are totally new to this please guide us.

Regards
Kasturi
Can someone help with this?

Thank you!!

Stijloor.
 
A

Angelika

#4
Hi Everyone!

Presently our company is certified for AS9100 Rev c, Now our management is decided to go for EASA Certification, What are the things we need to prepare like manual, Procedures, Templates we are totally new to this please guide us.

Regards
Kasturi
Hi Kasturi,

what kind of EASA certification do you want to obtain?

Regards,
Angelika
 
Last edited by a moderator:
B

Bleikur

#5
Dear Angelika,

judging from the many posts you have written in this forum you seem to know a lot about EASA, DOA and co. I bet there are many people out there very thankful. :applause:
By the way I studied Aerospace Engineering (Luft- und Raumfahrttechnik) at the University of Stuttgart.

Can you, or anybody else for that matter who is familiar with the DOA application process, tell me if I can somewhere find a guideline in which order to do things when applying for a small DOA company for the application process to be as short as possible?
For example:
  • Do I finish the DOH before I apply or do I first apply and then start writing the handbook?
  • Do I submit the staff description together with the application or do I submit it later?
  • How long does it take EASA to handle the DOA application?
  • How long does it take somebody to write the DOH full time?

The short version: In which order is it best to do things when applying for DOA to make the whole process as short as possible?

Best regards from Iceland,
Bleikur
 
Thread starter Similar threads Forum Replies Date
S City & Guilds Quality Assurance exam preparation (June) - Guidance needed Professional Certifications and Degrees 6
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Guidance for health institutions on in-house manufacture and use UK Medical Device Regulations 1
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
dgrainger Informational MHRA guidance on CE UKNI - Article 5.5 - 2021-02 EU Medical Device Regulations 0
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
Aymaneh AAMI TIR45 guidance wanted IEC 62304 - Medical Device Software Life Cycle Processes 4
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
dgrainger Informational UK guidance on Device regulation from Jan 2021 published UK Medical Device Regulations 19
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
B EU MDR Perscription product guidance EU Medical Device Regulations 1
John Broomfield Guidance on Safe Working During Covid-19 Pandemic Misc. Quality Assurance and Business Systems Related Topics 5
dgrainger Informational UK guidance on FSNs - May 2020 EU Medical Device Regulations 1
dgrainger Informational UK guidance on FSNs - Published 20 May 2020 UK Medical Device Regulations 1
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
dgrainger Informational MHRA updated guidance: Clinical investigations of medical devices – guidance for manufacturers Medical Device and FDA Regulations and Standards News 0
rob73 MDCG guidance on class 1 devices and MDR EU Medical Device Regulations 0
U Product Lifecycle Procedure Guidance Design and Development of Products and Processes 7
J CEN/TR 17223:2018 Guidance on the relationship between13485 and MDR.. worth the money?? ISO 13485:2016 - Medical Device Quality Management Systems 2
M Informational EU – Ongoing Guidance development within MDCG Subgroups Medical Device and FDA Regulations and Standards News 1
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Clinical Decision Support Software Medical Device and FDA Regulations and Standards News 0
M Informational DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
M Informational USFDADraft Guidance – Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
M Informational Several revised or updates USFDA guidance - 9/9/2019 Medical Device and FDA Regulations and Standards News 12
M Informational USFDA final guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational FDA draft guidance – Safer Technologies Program for Medical Devices Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom