Consultancy Services for Medical Devices & In Vitro Medical Devices
Background
In the European Union (EU) Regulatory compliance is one of the key elements to your success in this market, there are others such as marketing strategies. However, at Advena we focus on regulatory compliance, and we know this is weighing down heavily on manufacturers, it is becoming costly and burdensome to handle in-house, especially in companies where resources are stretched. Even more so since the EU has raised the standards for compliance with the introduction of Regulations (EU) 2017/745 (MDR) & 2017/746 (IVDR).
Advena can ease the drain on your internal resources by providing cost-effective solutions.
Technical Files
All medical devices under the MDR or the IVDR require a technical file in accordance with Annex II and Annex III of these regulations.
At Advena we have a team of professionals and can offer a range of services to meet your regulatory needs. Here is a selection of services available.
- Technical Documentation Compilation
- Gap Analysis / File Reviews
- Clinical Evaluation Plans & Reports (CER & CEP)
- Performance Evaluation Plans & Reports (PEP & PER)
- Risk Management File
- Device Classification.
- General Consulting.
Our service is specifically developed for start-ups and small to medium size entities who may not have the resources internally to cope with the increased regulatory demands of the EU.
Whether you need help in compiling a full technical file or some of the component parts of a technical file we have a cost-effective solution for you.
For more information and a quotation please contact us
Quality Management Systems (QMS) Consultancy
The ISO13485 Quality Management System standard describes the way a company should incorporate common sense control of their design processes, manufacturing, packaging, sterilisation and finish processing, and dispatch to the end user. In addition, the standard discusses the need for post-market activities through to the end the end of life of a medical device – Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF), so much that it is now considered as essential
Under Regulation (EU) 2017/745 (The MDR) & (EU) 2017/746 (The IVDR) a quality management system compliant to Article 10(9) is a mandatory requirement.
For all Class IIa, IIb and III medical devices produced under a full quality assurance system must be in accordance and certificated to ISO 13485, the current state of the art in medical device quality management system standards.
However, for Class I devices and Class A in vitro medical devices manufacturers should keep in mind that while a QMS is a mandatory requirement in accordance with Article 10(9) of both the MDR & IVDR a certificated QMS (e.g., audited by an accredited body) is not mandatory.
Appointing the Right Consultant is Crucial
At Advena we have a team of experienced professionals who possess the necessary expert knowledge and qualifications in regulatory affairs and quality management and can offer a range of services to meet your QMS needs. Our experts will help you create an efficient quality management system that minimises overheads and complexity and complies with ISO 13485 as well as the requirements of Article 10 of the MDR and IVDR.
Here is a selection of services available:
At Advena we make it easy to talk and communicate so we best understand your requirements. Therefore, if you are interested in any of our services, we will make ourselves available, just follow these simple steps:
- Reach out and contact us
- We can begin with a conference call over Teams or Zoom.
- We’ll introduce our team.
- Discuss your regulatory and/or QMS requirements.
- Following on from the discussion, we will provide a detailed quotation for your review.
- Additional conference calls can be arranged to discuss the quotation or project progress.
- At the completion of a project, a package of documents will be provided for your review. These documents are yours to keep and maintain. However, as always, we remain on hand should you require any amendments or need to make additions.
Why Choose Advena for Your Consultancy Projects?
- We have over 25 years’ experience in regulatory affairs.
- Our in-house team of experienced and professional consultants can offer a wide range of services to aid you with regulatory compliance including:
- Compling technical documentation in full.
- Clinical Evaluation Plans & Reports (CER & CEP).
- Performance Evaluation Plans & Reports (PEP & PER).
- Risk Management File.
- Device Classification.
- QMS in accordance with ISO13485 & Article 10 of the MDR & IVDR.
- Gap analysis/file reviews.
- Internal QMS audits.
- We are responsive, 91.1% of emails are replied to within 24-48 hours.
- We offer our service at competitive prices.
- Our QMS is certified to ISO 13485.
Years of experience
Advena Services Ltd benefits from over 25 years of regulatory experience by being part of the Advena group of companies and employs qualified individuals who possess the necessary expert knowledge of the regulatory requirements for medical devices. This knowledge is supported by academic qualifications and professional experience in regulatory affairs and quality management relating to medical devices. This makes us the ideal choice for your business.
Personal approach
We have a team of professionals who have the depth of knowledge needed to carry out the Importer obligations, our team provides a personal approach dedicated to placing the needs of our clients at the very top of our priorities while also recognising that the applicable EU regulations must be complied with. Just take a look at our Testimonial page.
Great Responsive support
We also understand that clients need to be able to reach out for help and advice and how important being responsive is, Advena is committed to supporting our clients and is always available to answer client’s questions and queries, and this is included as standard in our service. In fact, our client feedback survey found that 91.1% of emails were replied to within 24-48 hours.
Provided excellent guidance
We truly appreciate the cooperation and patience of the Advena staff. They have provided excellent guidance in helping us decide on the best course of… “Provided excellent guidance”
True experts to turn to
Working with Advena has made our entry into the EU medical device market possible. They patiently and skillfully and timely respond to an endless stream… “True experts to turn to”
Quality of services
I have used Advena as part of another company and I have contracted them again for the quality of services and reasonable fees. The newsletter… “Quality of services”
Fully professional and supportive
I have worked with Advena on the Regulatory side of our business now for more than 10 years. The service provided during this time has… “Fully professional and supportive”
You guys are the best, as always providing service, support and partnership
Thank you so much! You guys are the best, as always providing service, support and partnership. Much… “You guys are the best, as always providing service, support and partnership”
For More Information Concerning Our Consultancy Service that
- Has over 25 years’ experience in regulatory affairs.
- Are in tune with notified body requirements and expectations.
- Experienced with the MDR and IVDR.
- Allows you to benefit from our extensive experience and knowledge.
- Offers regulatory guidance and opinion.
- Answers your questions in a responsive manner.
- Is certified to ISO13485.
- Is cost effective.
Contact us for a free quotation/proposal.
