Our services for the Pharmaceuticals and Medical Devices industry

Compliance

We support you in drafting your quality and regulatory documents, in setting up your quality system or in improving your compliance with EU and US GMP – GDP – ICH Guides – 2017 regulations 745 and 746 – 21 CFR 820 – – NF EN ISO13485 …

Examples of services:

  • Preparation of inspections (ANSM, FDA, etc.)
  • Supplier audits, audits of subcontractors
  • Assessment of quality documentation: deviation reports and investigation tools, CAPA plan, change management, responses to customer complaints …
  • Creation of quality documents: quality specifications, Quality Manual, CE marking technical files, 510k …

 

Training

Cabinet Ace Performance offers various training themes that, by encouraging learning by experience and using a different pedagogical approach, resulting from coaching, assure you an undeniable competitive advantage.
Alone or in combination with a coaching service, these trainings bring you knowledge and know-how essential to the development of your company.

Here are some examples below :

  • How can we set up an efficient and compliant quality organization?  From know how to expertise
  • Qualification process of investigators
  • Medical Devices Regulations
  • Soon inspected by the FDA? : 2 days to prepare yourself !
  • Equipment qualification and process validation
  • GMP applied to Quality Control Laboratory

Contact us to receive the complete program

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Design and Marketing of Medical Devices

We support you from the Design to the Marketing of your Medical Devices thanks to our expertise in the following areas:

  • Choice of materials and technology
  • Design assistance and deployment of design  tools (AMDEC, Value Analysis, Work Factor)
  • Patent filing and industrialization
  • Production of kits for the Pharmaceutical Industry
  • Project monitoring, technical expertise for development and production, Lean Manufacturing
Call us
: +33 6 89 55 57 76
Email us
: a.niclas@ace-cabinet .fr
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Performance improvement

Our firm develops synergistic activities aimed exclusively at improving the performance of your organization, its tools and its people.
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Personalized support

You benefit from a long-term personalized support according to your Company’s needs by relying on experience-based learning.
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Rapid and sustainable development

Our comprehensive approach to performance gives you the advantage of rapid and sustainable development of your company and your employees.

CABINET ACE PERFORMANCE

Our priority: the compliance of your quality organization, the safety of your products.