What is rapid response consultancy?

Rapid response consultancy for medical device regulation can take a number of different forms. Broadly speaking, it’s ad hoc support designed to help your company find fast solutions to regulatory challenges. Here are some of the main services available:

• Audit and inspection preparedness – Immediate preparation and coaching for inspections or audits, particularly if they are unannounced or scheduled at short notice. We give you guidance on documentation, process adjustments, and team training to ensure your company meets the expectations of regulatory authorities like Notified Bodies in the EU or the FDA in the US.
• Regulatory strategy and gap analysis – Fast analysis of your existing regulatory strategies and documentation to identify potential weaknesses or areas that need urgent improvement to maintain or achieve compliance. We can advise you on alternative strategies when existing approaches are at risk of rejection, with a focus on meeting timelines and avoiding costly delays.
• Emergency regulatory support – Quick assessment and prioritization of compliance issues, whether due to recent regulatory updates, audit findings, or unexpected incidents like product recalls. We help you find solutions to address compliance gaps, helping you avoid regulatory penalties, market rejections, or delayed approvals.
• Regulatory submission and review support – Rapid review and revision of Notified Body Application forms, technical file submission dossiers, procedural and/or ISO certification documentation, to ensure you meet the submission timelines and requirements at short notice. We also provide quick turnaround assistance to make necessary changes in audit response documentation or to post-market surveillance reportings ensuring continued quality and regulatory compliance.
• On-demand expertise and training – Access to regulatory experts who can provide real-time, hands-on guidance to internal teams, helping them understand and implement compliance requirements efficiently. Often used is our quick device qualification or classification assessment. Also we put together customized training sessions to quickly upskill team members on the latest regulatory updates and standards applicable to specific products or markets.
• Risk mitigation and crisis management – Developing a swift action plan to address high-risk compliance issues, such as those involving patient safety, quality management, or regulatory filing errors. We support you with crisis communications and strategy to manage urgent situations, especially in cases where regulatory bodies may intervene.

Why does regulatory compliance need a rapid response?

The regulatory requirements imposed on medical device manufacturers are highly stringent, and rightly so. No one wants a malfunctioning or faulty device to impact patient care. But under the Medical Device Regulation (MDR) the certification and approval process can take years. For startups and small businesses, that’s a long time to wait without generating revenue; it could even spell the end for some products. That’s why there’s a need for speed when resolving compliance issues.

Through expert intervention, rapid response consultancy improves the likelihood of regulatory approvals, smoothing the path to market access. Fast, high-quality solutions help you mitigate delays in product approvals and market entry. Taking action quickly can also help you avoid fines, recalls, or other penalties from regulatory breaches. On top of that, hands-on, rapid support equips your internal teams to manage future regulatory challenges with confidence.

One of the major drivers for rapid response consultancy – especially under the EU’s MDR – are regulatory changes and revisions which impact timelines for compliance. For example, at the moment the three to five-year cycle for certificate renewal is creating a lot of work for small and midsize businesses (SMBs) and the Notified Bodies (who are already dealing with a huge backlog of cases). 

Time is always an important factor in regulatory compliance for one simple reason: the more time you spend on being compliant, the more likely it is you’ll avoid issues that could impact your ability to bring the product to market and keep it there. 

Regulatory expertise when you need it most

Time always matters, but it can’t solve everything when it comes to regulatory compliance. You also need timeliness and the right experience and expertise on hand to navigate the compliance process and handle change management. 

One of the major challenges of regulatory compliance for medical device companies is finding someone with the right expertise to fill the role of QA/RA (or equivalent). Specialized expertise is scarce, and good people are in demand, so when a company loses an experienced QA/RA it can be hard to replace them or find someone already within the organization with the right skills to take on the role. 

In smaller companies, it’s not always possible to blend the responsibility for regulatory compliance with other roles and responsibilities. To some extent, there can even be a conflict of interest. For example, if someone in sales and marketing takes responsibility for regulatory compliance, it’s not a good fit.

It’s also a myth that a background in quality control is a good fit for the role. Sometimes we work with companies who’ve hired a quality controller, not a quality manager. There’s a key difference. Quality control is about product testing, whereas quality management is about understanding complex regulations and correctly completing documentation. For that reason, anyone with a scientific or legal background and the ability to understand complex documentation is a good candidate for QA/RA.  

It can be even harder for startups with limited resources to hire a dedicated person with the right expertise. Rapid response consultancy can help you fill those shoes at an affordable price. But it offers even more value than that. As mentioned earlier, the true value of our regulatory consultancy for startups and small businesses is the training we provide to equip your people with the skills needed to handle regulatory compliance on your own. 

Compliance professionals you can count on

We get it. Navigating regulatory compliance is often the last thing that an innovative medtech startup wants to do. So it gets put on the back burner. But in this industry, regulatory compliance sits front and center. That’s why it makes total sense to hand it over to a regulatory expert who can give you peace of mind that everything is being completed on time.  

Even if you have a highly complex medical device, it doesn’t take long (typically days or weeks) for our specialists to get up to speed and start working to help solve your regulatory challenges. And for cash-strapped startups, we can provide a set of affordable options, including training on how to tackle regulatory compliance on your own. 

In addition, we can even temporarily fill roles like QA/RA Manager, PRRC, Vigilance Officer or Risk Management Facilitator bringing our own expertise from Peercode as a legal manufacturer of MDR Software as a Medical Device (SaMD). That means we’re also the right people to speak to when it comes to your Quality Management System (QMS) and conformity with ISO 13485 - The standard for Quality Management Systems for medical device manufacturers.

Looking for a rapid response consultancy to support regulatory compliance for your medical device? Peercode Regulatory Consultancy can help. Talk to one of our specialists about your regulatory challenges, today. Contact us