Medical Devices - Project Services
Procorre offers our global clients a complete range of services to ensure their medical and in-vitro devices are compliant with the latest regulations.
We have established an excellent working relationship with all the Notified Bodies in Europe since 1996 and are recognised world leaders in our field of expertise. Our continued success is built on these strong relationships and a thorough knowledge of the processes required to achieve the CE mark.
We represent both your business and products through the registration for the CE mark, complaint handling and deal with any incident reports which may arise in the future.
We are able to effectively manage all of your CE marking requirements across the world.
We will ensure you secure and retain the CE mark for your products, whether you are looking to gain a CE mark for a Class A, B, C or D medical device, (as former lead auditors for SGS and GMED) we have the specialist experience and knowledge to guide you through this process.
Our highly trained consultants, who work with clients worldwide, are fully conversant with the MDD 93/42/EEC and the updates required within 2007/47/EEC Directive as well as the new ISO13485: 2016 version.
We offer clients a complete range of services from risk assessment and product registration through to incident reporting.
We will ensure you gain and retain your CE mark in both a timely and cost effective manner.
Our qualifications as lead auditors for Notified Bodies provides us with a thorough understanding of what the Notified Bodies require; we are able to help you develop your quality management system (QMS) and update it to the latest regulations including procedures for post market surveillance and post clinical follow up.
We will ensure both your QMS and products stay in line with the constantly evolving legislation across Europe.
Technical File Evaluation
As European law evolves so your technical files need to change too. We will ensure that not only does your technical file provide the blueprint for building your product, it also can withstand a future potential legal challenge in the event of a medical device incident involving your product.
Due to growing demands of regulatory and legal complexities in the medical device industry, even the largest companies are looking to outsource their regulatory affairs and quality assurance tasks - either to supplement an in-house team or to simply guarantee they have an expert in place.
Not having enough staff or the right personnel in quality assurance (QA) and regulatory affairs (RA), can prove both costly and damaging to your business.
Procorre are working in partnership with European Device Solutions Ltd to provide Outsourcing Support Services, to suit different levels of regulatory affairs and quality assurance tasks. From basic support of one day per week on-site for a minimum of 3 months to a long term contract Interim QA/RA Manager - we will guide your business through maintenance, regulatory compliance, improving QMS and achieving complete compliance.
Our services include:
- QA/RA Functions
- Complaint Processing
- CAPA Processing
- Adverse Event Determination
- Internal Audits
- Supplier Controls
"European Devices Ltd. (specifically Paul Rowden) assisted Medicina Ltd. with our QMS upgrade to ISO 13485:2016, and the upgrade of our CE Marked Technical Construction Files over a twelve month period.
Medicina Ltd. successfully passed our ISO 13485:2016 with no major findings, and also retained our CE Marks with our Notified Body.
We would have no hesitation recommending Paul/his company to any other medical device / IVD companies seeking similar support."
Tracey Macdonald, CFO
"Paul Rowden first came to our company back in 1996, and although we were originally very sceptical about the whole ISO/CE marking process, Paul guided us through ISO 13485 certification, and we gained our CE mark at the first attempt. Paul has supported us from that moment on, as a consultant and as our European Authorised Representative in our CE marking re-registration process. We would highly recommend Paul to assist you with your CE marking activities."
Essential Dental Systems, Operations Director
Procorre working in partnership with European Device Solutions Ltd.