New regulations
RA strategy
Interim Management
FDA Inspection
Quality Management
Please also feel free to contact us for individual assignments.
New or revised regulations may affect your product portfolio. The preparation of new regulatory submissions for products already marketed for years represents a challenge for your regulatory team.
Examples of revised regulations in EU included the directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements implants as well as the directive 2007/47/EC amending the Active Implantable Medical Device Directive (AIMDD 90/385/EEC), and Medical Devices Directive (MDD 93/42/EEC) directive.
The next major change – expected in the 1st quarter 2017- is the publication of the Medical Device Regulation (MDR) to replace the current Medical Device Directive (MDD). In addition the international regulatory landscape is changing rapidly. Some countries established their first regulatory system in the past years (e.g. ASEAN countries), whilst other countries significantly revised their existing regulations (e.g. LATAM countries such as Mexico and Brazil)
How meditec Consulting can be of service?
Let us maintain your existing product registrations while your internal staff is focused on supporting product innovations.
We can help you in:
- defining a grouping strategy, which drives the number of submissions needed for the desired portfolio
- compiling the regulatory submissions or master files
- coordinating correspondence with your Notified body or competent authorities
- monitoring the overall status for different products and periodic reporting to senior management
Rapid technological advancements lead to innovative health care products that provide alternative treatment options. Your novel device might pose regulatory challenges in that the same product might fall under different regulatory schemes in different countries. It can also be that there is no or limited guidance available about the data requirements to obtain regulatory approval for this product.
How meditec Consulting can be of service?
A regulatory strategy and an early collaboration with the involved parties are important to shorten the time to market. We support you in developing a regulatory strategy having a global picture in mind and in ensuing negotiation with the relevant authorities and stakeholders.
If regulatory or quality is only part of your responsibility, the outsourcing of a regulatory or quality function is an interesting option. While medium size and large companies have specialized regulatory and quality departments, the regulatory or quality function in smaller organizations is shared with other responsibilities. Depending on your product and target markets, the regulatory and quality environments are complex and the determination and implementation of requirements is time consuming.
How meditec Consulting can be of service?
Our consultants can help you to determine the most efficient regulatory pathway for your product, implement the necessary quality system procedures, and assist you in preparing quality manuals, technical files, design dossiers or regulatory submissions.
Your company is growing and you need time to find the right candidate for your regulatory or quality group. A member of your team leaves for a sabbatical or is on maternity leave.
How can meditec Consulting be of help?
One of our consultants joins your team until the open position is filled or continues the work until your staff member returns.
In case an FDA inspection is announced and you don’t know what to expect or need additional support for your inspection team.
How meditec Consulting can be of service?
We can help you understanding the differences and similarities between the FDA QSR and ISO 13485 as well as introduce you to the FDA’s Quality System Inspection Technique. We can conduct a Mock-Audit, which is a suitable way to prepare your staff. During the inspection, meditec Consulting can act as a facilitator in the communication with the FDA inspector. Finally, we can support you in addressing FDA 483 observations to avoid Warning letters or enforcement actions.
You are starting a business in the healthcare industry and need to establish a quality system.
How can meditec Consulting be of help?
meditec Consulting can assist you in creating the quality manual, quality system procedures and associated templates. We can prepare training materials and train your staff accordingly.
How meditec Consulting can be of service?
Based on our experience with process optimization and implementation of quality management systems, meditec Consulting can help you improve your operational efficiency.